83 FR 47352 - Brian Thomas Nichol, M.D., Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 182 (September 19, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 182 (September 19, 2018)
| Page Range | 47352-47369 | |
| FR Document | 2018-20383 |
[Federal Register Volume 83, Number 182 (Wednesday, September 19, 2018)] [Notices] [Pages 47352-47369] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20383] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 16-22] Brian Thomas Nichol, M.D., Decision and Order On March 14, 2016, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Brian Thomas Nichol, M.D. (Respondent), which proposed the revocation of his DEA Certificate of Registration No. BN4578057, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of 5106 McLanahan Drive, Suite B, North Little Rock, Arkansas. Administrative Law Judge Exhibit (ALJ Ex.) 1, at 1. As grounds for the proposed action, the Show Cause Order alleged that Respondent's ``registration would be inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f), 824(a)(4)). For the same reason, the Order also proposed the denial of any of Registrant's ``pending applications for renewal or modification of such registration, and . . . any applications for any other DEA registrations.'' Id. More specifically, the Show Cause Order set forth six independent reasons why the Government alleges that Respondent's registration should be revoked. Id. at 1-3. The Show Cause Order first charged that Respondent's ``pre-signing of prescriptions for controlled substances violated [21] \1\ CFR 1306.05(a).'' Id. at 2. The Order states that this charge is based on the allegation that in 2006, the Arkansas State Medical Board found that Respondent violated Arkansas and federal laws when (1) he ``pre-signed controlled substance prescriptions, which [his] staff members, who were not authorized by law to issue such prescriptions, then issued to patients'' and (2) he ``[was] not present and [was] not consulted by [his] staff when such prescriptions were issued.'' Id. at 1-2. The Order further alleged that in 2006, as a result of these findings, the Arkansas Board suspended Respondent's medical license for six months. Id. at 2. --------------------------------------------------------------------------- \1\ Although the Order erroneously referenced Title 42 of the Code of Federal Regulations for this violation, Government counsel corrected the error during his Opening Statement at the administrative hearing when he made clear that Title 21 was the title that the Government had intended to allege. See Transcript (Tr.) 18. Respondent raised no objection based on the erroneous title reference, and I find that this error was merely a scrivener's error and that Respondent had adequate notice of the charged violation. --------------------------------------------------------------------------- The Show Cause Order also set forth five charges of recordkeeping violations based on DEA's July 4, 2014 ``on-site inspection of [Respondent's] registered location.'' Id. First, the Order charged that Respondent ``failed to maintain an initial inventory of all controlled substances in violation of 21 U.S.C. 827(a)(3) & 842(a)(5) and 21 CFR 1304.11(b).'' Id. Second, the Order charged that he ``failed to maintain complete and accurate dispensing records in violation of 21 U.S.C. 827(a)(3) & 842(a)(5) and 21 CFR 1304.21(a).'' Id. at 2-3. Third, the Order charged that, during the on-site inspection, Respondent ``could not provide a DEA-222 order form dated [January 16, 2014], for an order of oxycodone tablets, in violation of 21 U.S.C. [842](a)(5) and 21 CFR 1305.17(a).'' \2\ Id. at 3. Fourth, the Order [[Page 47353]] charged that Respondent ``failed to properly annotate two DEA-222 order forms in violation of 21 U.S.C. 842(a)(5) and 21 CFR 1305.13(b).'' Id. Fifth, the Order charged that Respondent ``failed to maintain [his] inventory and dispensing records at [his] registered location and these records were not readily retrievable, in violation of 21 U.S.C. 842(a)(5) and 21 CFR 1304.04.'' Id. Related to this last charge, the Order alleged that Respondent's ``inventory and dispensing records were located at Moore Clinical Trials,'' which was not located at his registered address, and that he ``had not asked for permission to store controlled substance records at a central location'' in violation of 21 CFR 1304.04(a)(1). Id. --------------------------------------------------------------------------- \2\ Although the Order erroneously referenced an August 28, 2013 DEA 222 form for this charge, the Government corrected the date of the allegedly missing DEA 222 form to January 16, 2014 in its May 12, 2016 Prehearing Statement and during Government counsel's Opening Statement at the administrative hearing. See ALJ Ex. 7, at 8; Tr. 15. In addition, although the Order erroneously referenced Section 821 of Title 21 of the United States Code for this charge, the Government corrected the error in its May 12, 2016 Prehearing Statement to Section 842 of Title 21. See ALJ Ex. 7, at 8 (``Respondent's failure to provide the DEA-222 form for this shipment was in violation of 21 U.S.C. 842(a)(5) and 21 CFR 1305.17(a).''). I find that these errors were merely scrivener's errors and that Respondent had adequate notice of the charged violation. --------------------------------------------------------------------------- Although the pending Show Cause Order discussed a prior September 27, 2011 Show Cause Order that DEA issued to revoke Respondent's DEA registration, as well as the terms of an April 27, 2012 Memorandum of Agreement (MOA) that was intended to resolve the charges in that prior Order, the pending Order did not expressly charge Respondent with violating the MOA. See id. at 2. Instead, the Government charged Respondent with violating the MOA in its May 12, 2016 Prehearing Statement, and further alleged that these violations constituted an independent basis to revoke his registration. See ALJ Ex. 7, at 10-11, 11 n.4.\3\ --------------------------------------------------------------------------- \3\ ``[P]leadings in administrative proceedings are not judged by the standards applied to an indictment at common law.'' Moore Clinical Trials, L.L.C., 79 FR 40145, 40159 n.34 (quoting Citizens States Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984)) (internal citations and quotations omitted). ``An agency is not required to give every [Respondent] a complete bill of particulars as to every allegation that [he] will confront.'' Id. (quoting Boston Carrier, Inc. v. ICC, 746 F.2d 1555, 1560 (D.C. Cir. 1984)) (internal citations and quotations omitted). ``Thus, the failure of the Government to disclose an allegation in the Order to Show Cause is not dispositive, and an issue can be litigated if the Government otherwise timely notifies a respondent of its intent to litigate the issue.'' Id. (quoting George Mathew, M.D., 75 FR 66138, 66146 n.20 (2010)); see also Darrell Risner, D.M.D., 61 FR 728, 730 (1996) (``the parameters of the hearing are determined by the prehearing statements''). --------------------------------------------------------------------------- After service of the Show Cause Order, Respondent, through his counsel, made a timely request for hearing. See ALJ Ex. 2. The matter was placed on the docket of the Office of Administrative Law Judges and assigned to Administrative Law Judge Charles Wm. Dorman (hereinafter, ALJ). On May 19, 2016, the parties participated in a telephonic prehearing conference, which was not transcribed, and the ALJ issued a Prehearing Ruling and Protective Order (ALJ Ex. 9) memorializing 12 accepted stipulations of fact (set forth more fully infra) as well as the terms of a protective order. Following other pre-hearing procedures, the ALJ conducted an evidentiary hearing in Little Rock, Arkansas on August 16-17, 2016, at which both parties elicited testimony from witnesses and submitted various exhibits.\4\ --------------------------------------------------------------------------- \4\ On August 23, 2016, Respondent filed a Motion to Supplement the Record requesting that the ALJ accept new exhibits. ALJ Ex. 14. Specifically, Respondent requested leave to supplement the administrative record with the back pages of certain DEA 222 forms entered into evidence at the hearing to rebut a Government witness's testimony about the instructions contained on those back pages. Id. at 1-2. Respondent also attached to his motion the affidavit of Matilda Buchanan, who identified and copied these DEA 222 form back pages for purposes of the motion and who prepared the proposed exhibits. See Exhibits 1-2 to ALJ Ex. 14. On August 29, 2016, the Government filed its ``Opposition to Respondent's Motion to Supplement the Record and Government's Motion for Leave to File Responding Affidavit.'' ALJ Ex. 16. As a threshold matter, the Government contended that Respondent failed to establish that he had good cause for failing to identify the back pages of the DEA 222 forms as exhibits by July 26, 2016, when supplemental prehearing statements were due--even though Respondent knew that the DEA 222 forms would be introduced and discussed at the hearing. Id. at 1-2 (citing 21 CFR 1316.57), 5. The Government argued that Respondent's post-hearing motion was an attempt ``to rectify his perceived oversights made at the hearing'' for failing to introduce these back pages as part of his case, during cross-examination of the Government's witness, or in a rebuttal case. Id. at 3. The Government also argued that, in any event, Respondent had failed to establish a proper foundation for these supplemental exhibits, and that the Government can no longer cross-examine Respondent's affiant, whose affidavit was submitted in support of these exhibits. Id. at 3-4. Finally, the Government requested leave to file its own affidavit in response to Respondent's affidavit in the event the ALJ granted Respondent's motion. Id. at 5. On the same day, the ALJ issued an order denying Respondent's Motion. ALJ Ex. 17. The ALJ found that Respondent did ``not set forth any reasons in his Motion for failing to submit these additional exhibits by the July 26, 2016 deadline.'' Id. at 2. The ALJ also found that ``Respondent had the originals of these exhibits at the hearing and made no attempt to offer the back side of the 222 Forms into evidence at that time. Therefore, the Respondent has not established the requisite good cause for failing to submit these exhibits in a timely manner.'' Id. Finally, the ALJ found that admitting ``Respondent's proposed exhibits would be unfairly prejudicial to the Government'' because it ``no longer ha[d] the opportunity to cross-examine Buchanan on the production of the Respondent's additional exhibits, or to introduce additional rebuttal testimony or evidence.'' Id. I agree with the ALJ's ruling. --------------------------------------------------------------------------- The parties submitted briefs of their proposed findings of fact, conclusions of law, and argument on October 3, 2016, and the ALJ issued his Recommended Decision (R.D.) on December 5, 2016. The ALJ found that the Government sustained only two of its charges. First, the ALJ found that the Government had sustained its first charge that Respondent pre- signed prescriptions in violation of 21 CFR 1306.05(a). R.D., at 30. However, the ALJ also found that Respondent ``has presented sufficient mitigating evidence'' concerning this charge ``to show that he can be entrusted with a DEA registration.'' Id. at 42. As a result, the ALJ did not recommend any sanction as a result of this violation. See id. at 41-46. Second, with respect to the Government's recordkeeping charges, the ALJ only sustained the Government's fourth recordkeeping charge ``that the Respondent failed to properly record the date he returned controlled substances to [his supplier] and the amount he returned.'' Id. at 45. The ALJ found that, although this recordkeeping violation also constituted a violation of the MOA, it was not a sufficiently ``significant violation'' of the MOA to warrant revocation. Id. at 40 (emphasis omitted). The ALJ also recommended that I find that this failure was ``mitigated by the fact that the Government has presented no evidence that Respondent had been previously cited for this type of recordkeeping failure or that this recordkeeping failure . . . is in any way related to the Respondent's day to day treatment of his normal patients.'' Id. at 45. The ALJ concluded that he ``would be exceeding the scope of [his] responsi[bil]ities were [he] to recommend that the Respondent's [registration] be revoked.'' Id. The ALJ added that he ``would reach the same conclusion even if the Government had proven all of its allegations in this weak case.'' Id. Thus, the ALJ recommended that I not revoke Respondent's registration and that I approve any pending application for renewal. Id. The ALJ further recommended that I find that the testimony of the Government's sole witness was not sufficiently credible to support any of the Government's remaining recordkeeping charges. See, e.g., id. at 4, 15 n.17, 19 n.25, 21 n.28, 34. Nonetheless, the ALJ found that this recordkeeping violation ``merits the imposition of a sanction'' and found that ``Respondent's recordkeeping violation to be egregious . . . because it prevented the DEA from being able to use the Respondent's own records to conduct an accurate audit of the [[Page 47354]] controlled substances for which the Respondent was accountable.'' Id. at 45. As a result, the ALJ recommended that I place the following five restrictions on Respondent's registration: 1. That he may not participate in any drug studies in which he is required to order, maintain, store, or dispense controlled substances for a period of four years. 2. That he may not order, maintain, store, or dispense any controlled substances at his registered location for a period of four years. 3. That restrictions one and two, above, will not be lifted, even after four years, until the Respondent has completed a course in controlled substance recordkeeping, a course in controlled substance storage, and a course in the administration of controlled substances, and provides the DEA with evidence of completion of these courses. These courses may not be used to meet any continuing medical education requirement. 4. That prior to renewal of the Respondent's [DEA registration], he sign a document consenting to inspections by DEA personnel of his medical practice without the need for DEA personnel to obtain an administrative inspection warrant prior to conducting an inspection. By the terms contained in the consent form, the consent shall be valid for four years from the date his current renewal application for a [DEA registration] is approved. This consent form is to be delivered to the Respondent's local DEA Field Office. 5. That prior to renewal of the Respondent's [DEA registration], he sign a document consenting to the conditions set forth in Paragraphs one and two above and acknowledging his understanding that his failure to comply with the terms of those conditions will constitute an independent basis for administrative enforcement proceedings by the DEA. This consent and acknowledgement document shall be delivered to the Respondent's local DEA Field Office. Id. at 46. On December 19, 2016, Respondent's counsel filed a ``Notice of Respondent's Intent to Comply with Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision'' in which he stated that Respondent ``intends to immediately comply with the Court's Recommended Disposition.'' ALJ Ex. 23, at 1. Respondent also stated that he executed a document attached as Exhibit A to his Notice entitled ``Consent to Conditions and Acknowledgment.'' See id. On December 23, 2016, the Government filed Exceptions to the Recommended Decision. ALJ Ex. 24. In its Exceptions, the Government contended that the ALJ committed error in finding that Respondent was a more credible witness than the Government's witness, a Diversion Group Supervisor (GS). Id. at 2. The Government further argued that accepting the credibility of the testimony of the GS over Respondent's testimony would require sustaining the Government's remaining recordkeeping charges because the ALJ's recommendations regarding those charges ``hinge[d] on his evaluation of the credibility of the Government's investigator and the Respondent.'' Id. at 2 & n.3. Respondent did not file a response to the Government's Exceptions. Thereafter, the ALJ forwarded the record to me for final agency action. Having considered the record in its entirety, including the Government's Exceptions, I agree with the ALJ's conclusions that the Government failed to prove its first, second, third, and fifth recordkeeping charges that Respondent failed to maintain an initial inventory, maintain complete and accurate dispensing records, provide the DEA 222 form dated January 16, 2014, and maintain his inventory and dispensing records at the registered location. I also agree with the ALJ that the Government sustained the Show Cause Order's first charge regarding Respondent's pre-signing of prescriptions and the Order's fourth recordkeeping charge regarding Respondent's failure to properly annotate two DEA 222 forms. Furthermore, I agree with the ALJ that the sustained fourth recordkeeping charge also constituted a violation of the MOA. Finally, I also agree that Respondent has accepted responsibility for both of these charges. Most importantly, while I agree with the ALJ that the sum of Respondent's misconduct does not warrant revocation of Respondent's registration, I disagree with the ALJ's recommendation that the sanction in this case should be limited to the ALJ's recommended restrictions to Respondent's registration. Accordingly, and for reasons I set forth more fully below, I conclude that the relevant factors support suspension of Respondent's registration for a period of one month, in addition to the imposition of the restrictions that the ALJ recommended following termination of the suspension. As the ultimate fact finder, I make the following findings of fact. Findings of Fact Respondent is the holder of DEA Certificate of Registration BN4578057, pursuant to which he is authorized to dispense controlled substances in schedules II through V as a practitioner, at the registered address of 5106 McLanahan Drive, Suite B, North Little Rock, Arkansas. See Attachment to ALJ Ex. 7; Respondent's Exhibit (hereinafter RX) A, at 1. Respondent's registration was due to expire on October 31, 2016. See id. On September 12, 2016, Respondent submitted a renewal application.\5\ Government's Proposed Findings of Fact and Conclusions of Law (ALJ Ex. 20), at 1 n.2. Because Respondent has submitted a timely renewal application, I find that Respondent's DEA registration has remained in effect pending the issuance of this Decision and Final Order. See 5 U.S.C. 558(c); Perry County Food & Drug, 80 FR 70084, 70089 n.17 (2015). --------------------------------------------------------------------------- \5\ The parties stipulated that Respondent had previously renewed his DEA registration on December 9, 2010 and on October 21, 2013. ALJ Ex. 9, at 2. --------------------------------------------------------------------------- Respondent is an allopathic physician who is licensed to practice medicine in Arkansas. Transcript (Tr.) 137; RX D. His specialty is anesthesiology, and his current medical practice focuses on pain management. Tr. 32, 137-38. During the hearing, Respondent submitted evidence establishing that his Arkansas license to practice medicine was active and due to expire on April 30, 2017. RX D, at 1. I have reviewed the official website of the Arkansas State Medical Board (ASMB), and it shows that his Arkansas medical license is still active and is now due to expire on April 30, 2019. Thus, I take official notice that Respondent currently holds an active license to practice medicine from the ASMB.\6\ --------------------------------------------------------------------------- \6\ Under the Administrative Procedure Act (APA), an agency ``may take official notice of facts at any stage in a proceeding-- even in the final decision.'' U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA's regulations, Respondent is ``entitled on timely request to an opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within 15 calendar days of service of this order which shall commence on the date this order is mailed. --------------------------------------------------------------------------- The Prior Criminal and Administrative Proceedings The parties agreed to 12 stipulations, most of which relate to Respondent's prior criminal and administrative proceedings. Prior State Administrative Proceedings The parties stipulated that on June 8, 2006, the ASMB issued an Emergency Order of Suspension suspending Respondent's Arkansas medical license. ALJ Ex. 9, at 1. The Order alleged that Respondent violated Ark. Code Ann. Sec. Sec. 17-95-409(a)(2)(e), 17-95-409(A)(2)(g), and 17-95-704(E)(1), (2) and federal laws ``regulating the possession, distribution, or use of narcotic or controlled drugs'' because ``he prescribed or administered scheduled drugs intended to manage [[Page 47355]] pain for a patient who had chemical dependencies on said controlled drugs and who was diverting said medication for his addiction.'' Government Exhibit (GX), at 1. This Order also alleged that more specifically, he has pre-signed prescriptions leaving the name of the patient, substance and the instructions for taking the medication blank and permitting his office personnel, who are not licensed physicians, to fill in the prescription. A prescription pad, which had all the prescriptions signed by Brian Thomas Nichol, M.D. with the rest left blank, was found in his office pursuant to a [federal] search warrant . . . on the 19th of April 2006.'' Id. at 1-2. In the same vein, the Order alleged that Respondent permitted such office personnel to dispense and administer scheduled medications to at least three patients, and fraudulently billed one of these patients for $22,600. Id. at 2-3. The Order further alleged that Respondent ``performed medical procedures and engaged in the practice of medicine in the State of Arkansas . . . while not having a valid Arkansas license'' to do so. Id. at 2. Based on these allegations, the ASMB found that Respondent's acts ``endanger[ed] the public health, safety and welfare'' and suspended his state license on an emergency basis pending a hearing. Id. at 3. The parties further stipulated that on August 17, 2006, the ASMB held an administrative hearing based on the allegations set forth in the ASMB's Emergency Order, and issued its Final Order on the same day. See ALJ Ex. 9, at 1; GX 2. The parties also stipulated that ``[t]he ASMB's final order did not include all of the allegations made in the `Emergency Order.' '' ALJ Ex. 9, at 2. However, the ASMB's Final Order does state findings that Respondent ``admitted in testimony that he has violated the laws of the United States and the State of Arkansas regulating the prescribing of scheduled medication, more specifically, he has pre-signed prescriptions, and not written on the prescription the name of the patient, the substance prescribed, and instructions for taking the medication.'' GX 2, at 1. The ASMB also found that Respondent admitted that he ``permitted his office personnel, . . . who are not licensed as physicians, nor authorized to prescribe medication, to fill in the blanks on the prescription pad and distribute them to patients, even without Dr. Nichol being present.'' Id. The parties stipulated that the ASMB found that this conduct violated Arkansas and federal laws. ALJ Ex. 9, at 1-2; see GX 2, at 3. As a result of these findings, it is also undisputed that the ASMB suspended Respondent's Arkansas medical license for six months and that the ASMB lifted this suspension on February 2, 2007. See ALJ Ex. 9, at 2; GX 2, at 3. I also find that, in its final order, the ASMB fined Respondent over $10,000 and directed him to complete ``courses in (1) Office Management, (2) The Prescribing of Scheduled Medication and [DEA] Laws and Regulations . . ., and (3) a course on boundaries.'' GX 2, at 4. During the hearing, Respondent testified that he ``did'' what ``was alleged to have happened'' by the ASMB in 2006. Tr. 162. That is, he admitted that he improperly pre-signed prescriptions for controlled substances and that he ``take[s] responsibility'' for it. Id. at 274. Respondent testified, however, that there were no allegations of ``diversions [sic] resulting from that'' conduct. Id. at 162. Respondent later testified more broadly that he agreed to the conditions of the MOA ``even though there was [sic] never any allegations of diversion.'' Id. at 174. However, the ASMB's earlier Emergency Order alleged that Respondent ``prescribed or administered scheduled drugs intended to manage pain for a patient who had chemical dependencies on said controlled drugs and who was diverting said medication for his addiction.'' GX 1, at 1 (emphasis added). More specifically, the ASMB also alleged that Respondent ``prescribed or administered controlled substances when he knew or should have known that his patient was utilizing the drugs for non-therapeutic purposes and was chemically dependent on said drugs.'' Id. at 3. Thus, while I accept Respondent's testimony that he admitted to improperly pre- signing prescriptions, I do not accept Respondent's statement that there were never any allegations of diversion against him. Based on Respondent's representation in his testimony, the ALJ found that Respondent has written every prescription himself since the expiration of the state's suspension. R.D., at 10 (citing Tr. 166). The Government introduced no evidence contradicting Respondent's testimony. Thus, I find that there is no evidence that Respondent resumed pre- signing prescriptions after his suspension by the ASMB. Prior Federal Criminal Proceedings The parties stipulated that on January 8, 2008, 11 months after the reinstatement of his state medical license, Respondent pled guilty in the United States District Court for the District of Arkansas to a one- count criminal information charging him with felony health care fraud under 18 U.S.C. 1347. ALJ Ex. 9, at 2; see also GXs 3-4. That federal court sentenced Respondent to five years of probation and directed him to pay $15,400.69 in restitution and criminal penalties. ALJ Ex. 9, at 2; GX 4, at 2, 4. It is also undisputed that the court terminated Respondent's probation period early on September 20, 2011. R.D., at 6; Tr. 8. The parties also stipulated that on October 20, 2008, the U.S. Department of Health and Human Services (HHS) excluded Respondent from participation in the Medicare and Medicaid programs for five years pursuant to 42 U.S.C. 1320a-7(a). ALJ Ex. 9, at 2; see GX 5. The parties agree that HHS removed this exclusion on August 11, 2014. R.D., at 7; Tr. 9. Prior DEA Administrative Proceedings The Group Supervisor testified that DEA ``first bec[a]me aware of Dr. Nichol'' in 2011 after DEA received an application for a registration as a researcher from Moore Clinical Trials. Tr. 28. ``[I]n the review of that application, we became aware that Dr. Nichol was associated with Moore Clinical Trials . . . we saw that there was a current research study going on[,] and we noticed several violations of [DEA regulations] and the Controlled Substances Act.'' Id. More specifically, she testified that DEA conducted an investigation of both Moore Clinical Trials and Respondent and ``looked at the records and found that the receiving records and dispensing records weren't up to the regulations.'' Id. at 28-29. As a result, DEA brought separate administrative actions against each of them in 2011--one against Moore Clinical Trials to deny its application for a DEA registration as a researcher, and the other against Respondent to revoke his DEA registration as a practitioner. See id. at 28-29; GX 6. With respect to Moore Clinical Trials, the GS testified that ``subsequently the application for Moore Clinical Trials was denied.'' Id. at 29. In fact, the Agency issued and published its final decision and order denying Moore Clinical Trials' application pursuant to an August 8, 2011 Show Cause Order. Moore Clinical Trials, L.L.C., 79 FR 40145, 40145 (2014). In that decision, the then-Administrator found that Moore Clinical Trials ``entered into a contract with Dr. Brian Nichol, an interventional pain management specialist, to perform clinical research for it pursuant to contracts it might obtain from CROs [contract research organizations].'' Id. at 40148. The then- Administrator noted the ALJ's finding that `` `the documents kept by Dr. [[Page 47356]] Nichol,' who was supervising . . . clinical trials on behalf of [Moore Clinical Trials], `were deficient' and that the order forms for Schedule II controlled substances (DEA-222) `were lacking.' '' Id. at 40147 (quoting ALJ's Recommended Decision). ``The ALJ also found that `Dr. Nichol transported controlled substances to [Moore Clinical Trials'] location,' where he was not registered to dispense them.'' Id. The then-Administrator also noted that ``the ALJ found that the evidence is clear that Nichol's records did not comply with the Controlled Substances Act or DEA regulations'' and `` `Nichol[] fail[ed] to meet his responsibilities as a registrant.' '' Id. The then-Administrator made additional specific fact findings in Moore Clinical Trials regarding Respondent. Specifically, she found that on March 30, 2011, Moore Clinical Trials and Respondent ``entered into a Clinical Trial Agreement (CTA) with Quintiles, to participate in the NKTR-118 \7\ long-term safety study.'' Id. at 40149. She further found that, during the investigation of Moore Clinical Trials, the DI in the case ``contacted Mr. Jim Phillips, Dr. Nichol's attorney,'' who ``acknowledged that Nichol was involved in the study and that he was transporting the controlled substances to [Moore Clinical Trials] and dispensing them.'' Id. at 40150. ``The DI also requested of Mr. Phillips that Dr. Nichol provide his records, including the dispensing records and the schedule II order forms (DEA Form 222).'' Id. The then- Administrator found that the ``evidence also shows that in response to the GS's request (through Dr. Nichol's attorney) for Dr. Nichol's dispensing records, Nichol provided the GS with the records.'' Id. at 40156. The then-Administrator accepted the GS's testimony that the original DEA 222 forms related to the NKTR-118 study ``were kept at Dr. Nichol's registered location'' and that ``the forms did not indicate the date the drugs were received and the quantity received.'' Id. at 40151 (internal quotations and citations omitted), 40156 (adopting GS's testimony that ``she examined the Schedule II order forms and noted that they had not been completed by indicating the date the drugs were received and the quantity received''). Ultimately, the then- Administrator concluded that ``the record clearly establishes that Dr. Nichol violated both the separate registration provision and DEA recordkeeping requirements.'' Id. at 40155.\8\ --------------------------------------------------------------------------- \7\ ``NKTR-118'' is the drug Naloxol 6a-methoxyhepta (ethylene glycol) ether. Id. at 40148. ``The [full] name of the study was: `An Open-Label 52-week Study to Assess the Long-Term Safety of NKRT-118 in Opioid-Induced Constipation (OIC) in patients with Non-Cancer- Related Pain.' '' Id. at 40148 n.4. \8\ The then-Administrator also found that ``it is undisputed that the dispensing record for each study--which Dr. Nichol provided--was not created until August 27, 2012, well after all of the dispensings were made. The CSA requires, however, that a dispensing record be `maintain[ed], on a current basis.' 21 U.S.C. 827(a)(3).'' Id. at 40156 (internal citations omitted). --------------------------------------------------------------------------- With respect to the instant charges against Respondent, the parties stipulated that DEA issued a Show Cause Order against Respondent on September 27, 2011 proposing the revocation of his DEA registration on the ground that it is ``based, inter alia, on the findings of the ASMB and respondent's exclusion from Medicare and Medicaid.'' ALJ Ex. 9, at 2; see also GX 6. More specifically, the 2011 Show Cause Order proposed to revoke his registration as ``inconsistent with the public interest'' based on three allegations. GX 6, at 1 (citing 21 U.S.C. 823(f), 824(a)(4)). First, the 2011 Order alleged that Respondent's pre-signing of controlled substances prescriptions, as found by the ASMB, warranted revocation. Id. (citing 21 U.S.C. 824(a)(3), (4)). Second, the 2011 Order alleged that Respondent's registration must be revoked because of his exclusion for five years from participation in a Medicare and Medicaid program under 42 U.S.C. 1320a-7(a). Id. at 2 (citing 21 U.S.C. 824(a)(5)). Lastly, the 2011 Order alleged that, ``[o]n or about September 17, 2010, [Respondent] contracted with a controlled substance researcher [Moore Clinical Trials] to administer controlled substances \9\ to research subjects. The owner/operator of this research clinic has no experience handling controlled substances, and you [Respondent] and the owner/operator [of Moore Clinical Trials] gave conflicting information about the operation of this research clinic.'' Id. --------------------------------------------------------------------------- \9\ The Memorandum of Agreement resolving the 2011 Order, discussed more fully infra, specified that the alleged controlled substance referenced in that Order's third allegation was NKRT-118. See GX 7, at 1. --------------------------------------------------------------------------- The parties have further stipulated that Respondent entered into an MOA with DEA to resolve the allegations in the 2011 Show Cause Order,\10\ and that the MOA became effective on April 27, 2012.\11\ ALJ Ex. 9, at 2; GX 7. The GS testified that the MOA was ``an intermediary step trying to get [Respondent] into compliance.'' Tr. 29.\12\ Both Respondent and his investigator/assistant, Matilda Buchanan, testified that the MOA was the product of back-and-forth negotiations by the parties. Id. at 173-74 (Respondent testifying that ``there was some negotiation back and forth before we settled on the final agreement'' and ``I think it was the third or fourth [version] that we were both able to agree to terms on''), 425-26 (Ms. Buchanan testifying that ``drafts were sent back and forth'' and that ``we went over line by line both what the MOA said and then what does that mean by what it said''). --------------------------------------------------------------------------- \10\ This stipulation is also consistent with how the then- Administrator characterized the MOA. Moore Clinical Trials, 79 FR at 40151 n.10 (``Notwithstanding these allegations [in the 2011 Show Cause Order], the Agency allowed Dr. Nichol to retain his registration subject to various terms and conditions'' set forth in a Memorandum of Agreement (MOA)); see also GX 7. \11\ The Special Agent in Charge for DEA's New Orleans Division approved and signed the MOA on April 17, 2012, Respondent and his counsel signed it on April 20, 2012, and DEA's counsel signed it on April 27, 2012. GX 7, at 4. \12\ The ALJ questioned this testimony based on his finding that that the MOA ``does not address any of the alleged violations contained in the 2011 [Show Cause Order].'' R.D., at 10. The ALJ's assessment is confusing for at least two reasons. First, the parties stipulated that the MOA does, in fact, resolve the 2011 Order's allegations against Respondent, ALJ Ex. 9, at 2, and the ALJ accepted the parties' stipulation. R.D. at 7. That the parties repeated the allegations from the 2011 Show Cause Order in the MOA itself, see GX 7, at 1-2, makes the fact that the parties intended the MOA to address and to resolve the 2011 Order's allegations irrefutable. Apart from the parties' agreement, the third allegation of the 2011 Order (though unartfully worded) clearly references Respondent's role in the operations of Moore Clinical Trials. As already noted, Moore Clinical Trials received its own Show Cause Order in August 2011, less than two months before the September 2011 Show Cause Order that was issued to Respondent. From there, Respondent and Moore Clinical Trials took two different procedural paths. Respondent entered into an MOA and retained his DEA registration subject to the MOA's conditions; Moore Clinical Trials went to hearing and the Agency issued a final decision and order denying its application for a DEA registration. As already noted, Moore Clinical Trials discussed Respondent's recordkeeping violations (which precede the ones in this case) at length. When comparing that discussion to the MOA, it is obvious that the MOA addresses the allegations against Respondent and reflects the ``intermediary step'' that the GS referenced in her testimony. See 79 FR at 40151 n.10 (``Notwithstanding these allegations, the Agency allowed Dr. Nichol to retain his registration subject to various terms and conditions'' set forth in the MOA). Second, in any event, even if the MOA had failed to address the allegations in the 2011 Show Cause Order, as the ALJ suggested, he failed to explain why that is relevant. What is relevant is the fact that Respondent and the Government agreed that the MOA resolved the 2011 Show Cause Order. --------------------------------------------------------------------------- The MOA imposed the following conditions, in pertinent part, on Respondent: 1. Respondent must ``abide by all Federal, State and local statutes and regulations relating to controlled substances.'' 2. Respondent must ``make and keep records of all controlled substances that he [[Page 47357]] prescribes, dispenses and administers at his DEA registered location. These . . . dispensing records shall include all the information . . . set forth and required by 21 CFR 1306.05(a) and 1304.21 where applicable. These . . . dispensing records shall be available for inspection as set forth in paragraph 4 of this Agreement.'' 3. Respondent must ``make and keep a legible log of all Schedule II-V controlled substances that he prescribes for his patients.'' 4. Respondent must ``retain the records of the prescribing, administering and dispensing records, as described in paragraph 2, at his DEA registered location and agrees to allow DEA personnel access to his controlled substance records for [these] records as described in paragraph 2 for purposes of verifying his compliance with this Agreement and with all Federal, state and local statutes and regulations relating to controlled substances.'' 5. ``During the duration of the Agreement, Dr. Nichol shall notify DEA in writing if he will prescribe, dispense, or administer controlled substances at any other location other than his DEA registered address or Springhill Surgery Center. . . .'' 6. Respondent ``shall not order or receive any controlled substances except for controlled substances that he orders and receives at his DEA registered location. . . . As the physician, who is contracted to administer the FDA approved study drug NKTR-118, [Respondent] will administer that drug at either his DEA registered location or at an approved site for the current drug study. . . . [Respondent] agrees that for the duration of this agreement if he is asked to participate in additional drug studies involving controlled substances, he will notify DEA in advance of commencing the study.'' 7. Respondent ``understands and agrees that any violations of the Agreement may result in the initiation of proceedings to revoke or immediately suspend and revoke his DEA Certificate of Registration. . . . DEA and [Respondent] agree this is a final agency action on all matters in dispute. DEA will not seek to revoke [Respondent's] DEA registration or deny any renewal applications unless [Respondent] substantially violates this Agreement or unless [Respondent] commits additional acts that constitute grounds under 21 U.S.C. 823(f) and 824(a).'' GX 7, at 2-4. The MOA also stated that these conditions would remain in effect for three years. Id. at 4. The Quintiles Clinical Trial and Study On July 11, 2012, Respondent, Moore Clinical Trials, and Quintiles, Inc. entered into a ``Clinical Trial Agreement Effective July 6, 2012'' (hereinafter, CTA) to conduct a study related to opiate induced constipation. RX N, at 1, 11; Tr. 35. The CTA prescribed a role for each party. Respondent was the ``principal investigator'' of the study. Moore Clinical Trials, located at 3508 JFK Blvd., Suite #1, North Little Rock, Arkansas, was the ``INVESTIGATIVE SITE'' for the study. RX N, at 1. And Quintiles was an independent contractor acting on behalf of the ``Sponsor'' of the study (Purdue Pharma, L.P.) and would ``arrange and manage'' the clinical trial. Id. This study was designed to be a double blind study in which Respondent would dispense oxycodone, which is a schedule II controlled substance, to study patients. Tr. 35, 182 (the study was a ``double blind, double dummy placebo controlled study''). However, because this was a double blind study, Respondent did not know what other type of medication a study patient received. Id. at 35, 184. Respondent first placed an order for controlled substances related to the study on December 3, 2012, and on December 31, 2012, he notified the GS (by letter from his attorney) that he was participating in the study. Id. at 93-94, 120-21; see RX R, at 1. In the letter, Respondent's attorney, Mr. Phillips, added that ``[t]his trial is to begin in January 2013. . . . [T]his notice is our compliance with paragraph 6 of the MOA. Dr. Nichol will only administer the study drugs at his DEA approved address.'' RX R, at 1. Although the complete email that the GS sent in response to Mr. Phillips' December 31, 2012 letter is not in the record, the January 17, 2013 letter that Mr. Phillips sent to the GS in response to that email was admitted into evidence. See id. at 3. Specifically, the January 17, 2013 letter states that it is in response to two questions posed in a January 11, 2013 email that the GS had sent to Mr. Phillips in response to his earlier letter. Id. The response to the first question apparently posed by the GS regarded when the study would begin and how long it would be. See id. Mr. Phillips stated that ``the study we referred to should begin January 2013. The study length is approximately 22 weeks for each subject enrolled. . . . Enrollment is ongoing until the clinical trial end points are met. In all likelihood, the study will be about a year in length.'' See id. The second response was to the GS's ``other question'' asking ``What is the location and your understanding of the `approved' DEA address?'' Id. Mr. Phillips stated that the address to which he was referring was Respondent's registered location of ``5106 McLanahan, Suite B, North Little Rock, AR 72116,'' and that ``[a]ll study drugs will be administered at this DEA- approved address.'' Id. Mr. Phillips' response to the first question is consistent with Respondent's testimony at the hearing. Specifically, he testified that ``we expected to start enrolling patients in the study . . . to start in Januaryish [sic].'' Tr. 401. Respondent testified that enrollment is when they have ``met all the qualifications for it and are actually starting to see me as a patient. That's enrolled.'' Id. There is no evidence in the record contradicting this testimony. Thus, I find that Respondent began enrolling patients for the Quintiles study in January 2013. Mr. Phillips' response to the second question is consistent with the GS's and Respondent's testimony regarding the study. The GS testified that it was her ``understanding that Dr. Nichol does the physical evaluations and actual dispensing of the controlled substances from his registered location.'' Tr. 36. ``[T]he other types of monitoring and testing is done at Moore Clinical Trials.'' Id. The GS further testified that it was her understanding that the study ``concluded in June of 2014.'' Id. Respondent testified that he first saw study patients in February 2013. Id. at 210-211. Respondent's dispensing log is also consistent with this testimony, showing that the first time he dispensed a controlled substance (here, oxycodone) to a patient as part of the study was February 18, 2013. RX U, at 1.\13\ Thus, I find that Respondent first dispensed controlled substances to study patients on February 18, 2013. Accord R.D., at 13. --------------------------------------------------------------------------- \13\ Respondent testified that he ``had seven or eight'' study patients who ``actually enrolled in the study and only one patient, I think, or two patients that completed this study all the way to the end.'' Tr. 358, 398 (``I had two [patients who] completed it''). Respondent defined ``completed'' as ``when they've gone through the full length of the study to . . . where they actually completed the study at the end.'' Id. at 401. --------------------------------------------------------------------------- During the term of the CTA, Quintiles and the Sponsor reserved the ``right to audit'' Moore Clinical Trials' ``facilities, records and documentation.'' RX N, at 6. Respondent testified that such audits included Quintiles inspectors visiting Respondent's office as well to review his study documentation. Tr. 189-90. Respondent testified that Quintiles' inspectors or monitors ``would do a complete inventory of all the narcotics.'' Id. at 190. Respondent also said that the monitors required him ``to get the inventory down to the serial number of each individual kit, down to the serial number of each individual bottle. Any returns that the patient had, they would count each individual one. They would account for those quantities.'' Id. Finally, Respondent stated that he would ask the monitor ``when she was wrapping things up is is [sic] my pill count fine. . . . And every time I had [[Page 47358]] full count of the narcotics. So there wasn't any diversion.'' Id. at 191. Most important, Respondent testified that Quintiles had provided records that allowed for a calculation of every controlled substance pill received and that Quintiles accounted for every pill at the end of the study. Id. at 187, 301. To support this claim, Respondent introduced a series of documents prepared by others which the ALJ admitted into the record. For example, Respondent introduced copies of a series of reports or reviews prepared by Quintiles (and obtained from Moore Clinical Trials) of Quintiles monitors' site visits to Respondent's office to ensure he was following the drug study protocol. See RX Y; Tr. 262-63, 378-79, 454-56. Respondent also introduced accountability logs kept at Moore Clinical Trials for the drug study. RX Z; Tr. 456-57. Finally, Respondent introduced copies of work records that Quintiles had created during site inspections and while conducting their inventories. RX AA; Tr. 457-58. However, none of these documents, separately or taken together, were sufficient to make an accurate pill count. Moreover, Respondent failed to introduce any other documentary evidence or testimony from a Quintiles employee corroborating Respondent's testimony that Quintiles' records allowed for an accurate ``pill count'' of the pills Respondent had received. Accord R.D., at 18 nn. 22-23. At the same time, the Government offered no documentary evidence or testimony from a Quintiles employee to rebut Respondent's testimony. See id. Indeed, it is equally possible for Quintiles to have done a ``complete inventory'' and found that Respondent's pill count was ``fine,'' and at the same time for Respondent to have nonetheless failed to maintain complete and accurate dispensing records pursuant to the CSA and as alleged in the Show Cause Order's second recordkeeping charge. Respondent's recordkeeping is what is at issue in this case, not Quintiles' recordkeeping. Without a showing by a preponderance of the evidence that the recordkeeping requirements of Quintiles and the CSA are coextensive, I find that Respondent's testimony regarding the Quintiles audits and documents in the record rests on too thin a reed for me to accord it meaningful evidentiary weight regarding whether Respondent's recordkeeping complied with the CSA and DEA's regulations. The July 9, 2014 On-Site Inspection Inspection of Respondent's Registered Location The parties stipulated that on ``July 9, 2014, while the MOA was still in effect, DEA conducted an on-site inspection of Respondent's registered location.'' ALJ Ex. 9, at 3. Three DIs participated in the inspection. See id.; ALJ Ex. 7, at 4 & n.1; ALJ Ex. 11, at 1 n.1. The DI who had lead responsibility for conducting the inspection was unable to testify at the hearing for medical reasons. ALJ Ex. 11, at 1 n.1. Although a third DI accompanied the GS and the lead DI who conducted the on-site inspection, that third DI also did not testify. Thus, only the GS testified on behalf of the Government at the hearing. Id. The GS testified that the DIs ``went to Dr. Nichol's registered location . . . to ensure that he was in compliance with the MOA.'' Tr. 31. Under the MOA, Respondent had agreed ``to allow DEA personnel access to his controlled substance records for the prescribing, administering, and dispensing records . . . for purposes of verifying his compliance with [the MOA] and with all Federal, state and local statutes and regulations relating to controlled substances.'' GX 7, at 2. Although the inspection was unannounced, Respondent allowed the DIs ``access onto the premises to review records . . . [a]nd he signed an actual Notice of Inspection.'' Tr. 99; see also id. at 31-32; July 9, 2014 Notice of Inspection (GX 8). The inspection period was from December 19, 2012 through July 9, 2014. Tr. 38, 62. The inspection took one hour, and the GS testified that Respondent's ``assistant Xeroxed for us the documents we needed.'' Id. at 102. Initially, the DIs asked Respondent where the ``study drugs'' were ``because at that point in time we didn't know the study had been completed.'' Tr. 99. Once it became clear that Respondent no longer had any study drugs and ``that there were no drug destructions during that time period or theft or losses'' (id. at 39-40), the GS testified that ``we asked for any incoming documents [sic] receipts. We asked for any inventories. We also asked for any outgoing records which could include dispensing records, returns, theft and loss reports, drug destruction. Anything showing the movement of controlled substances in or out of that registered location.'' Id. at 36-37. The GS stated that ``this is typical of any inspection.'' Id. at 36. When asked if she could ``be more specific about what inventories and dispensing records you specifically asked for,'' she responded that ``[w]e asked for an initial inventory . . . We asked for receipts. And because these are Schedule II controlled substances, we asked for DEA order form 222s.'' Id. at 37-38; see also id. at 102 (``We asked for dispensing records, inventories. . . . we ask for any kind of documents showing receipts or dispensations.''). She also testified that ``[h]e did not have an inventory on hand.'' Id. at 52. Respondent testified that he did not ``recall'' whether the GS had asked for his DEA 222 forms or dispensing logs and stated that he ``d[id]n't think'' she had asked for his inventory. Tr. 213. Instead, he stated that the DIs ``wanted my paperwork for the study.'' Id. at 212-13, 214 (``When they found out there weren't any drugs there to collect, they wanted the paperwork''). In response, Respondent stated that he made his DEA 222 forms ``available for Agent Barnhill to review,'' and the GS acknowledged that the DIs reviewed at least some of these forms. Id. at 39, 214; see also RX S. Respondent also stated that he ``kept a green binder with all of the computation charts'' (that Respondent stated included an initial inventory) and ``provided'' them and his dispensing log ``to the agents when they came to see me in my office on July 9th.'' Tr. 224, 226, 236-37; RX U; RX V.\14\ --------------------------------------------------------------------------- \14\ The ALJ recommended that I find that ``Respondent provided the DEA investigators his 222 Forms, his dispensing logs, and an initial inventory.'' R.D., at 15 (citing Tr. 214). In the testimony cited by the ALJ, however, Respondent only testified that he made the DEA 222 forms ``available for [the GS] to review.'' See Tr. 214. --------------------------------------------------------------------------- The GS acknowledged that Respondent ``did give us some documents'' and that the DIs reviewed these documents ``in his office.'' Tr. 101, 102 (``he showed us some documents''). The GS recalled that Respondent ``produced five DEA 222 order forms for purchase. And he gave us two DEA order forms for returns back to the supplier.'' Id. at 39; see GX 9 (DEA 222 forms submitted by the Government). During cross-examination, Respondent's attorney asked the GS: Q Did [Respondent] show you documents other than the 222 forms? He did, didn't he? A I don't recall that. Q You don't recall that? A No. Tr. 102-03. Whatever other documents Respondent may have provided to the GS, she did not recognize them as an initial inventory or as dispensing records. See id. at 39 (GS's testimony that Respondent ``was unable to produce the initial inventory that we requested. And he was unable to produce dispensing records''). The GS testified that she did not recall giving Respondent a ``written list [[Page 47359]] of items'' that the DIs had requested. Tr. 100. She also testified that she did not provide Respondent (1) a list of items that the DIs did in fact receive, (2) a list of items to which she had testified were missing, or (3) a list of items that the DIs photocopied on the date of inspection. Id. at 100-01, 112 (``Records can be fabricated. So, no, we don't leave a list. The records must be onsite when we arrive.''). Respondent testified that, had the DIs advised him that he was missing something, he would have provided it to them. Id. at 236. The GS's use of the phrase ``we'' or ``us'' is significant and occurs frequently throughout her testimony regarding the inspection. In these instances, she was either testifying to what she remembered hearing someone else (presumably, the lead DI) ask Respondent, e.g., Tr. 103 (GS testifying that she was ``present when [the lead DI] asked [Respondent] for documents''), or she was testifying to what she would typically request from a registrant during an inspection (or to both). See id. (GS's testimony that she did not ``take notes of what was asked for'' but noted that ``[i]t's the same things we ask for every time'').\15\ In any event, the GS did not testify that she herself made these requests of Respondent, and she did not ``take notes of what was asked for.'' Id. Thus, while the record is clear that the GS did not recall reviewing documents that she recognized as an initial inventory or as dispensing logs at Respondent's office during the inspection (id. at 39), the record is unclear whether the other two DIs reviewed and recognized what Respondent submitted were his initial inventory and dispensing logs.\16\ --------------------------------------------------------------------------- \15\ In its Exceptions, the Government argues that the GS's ``use of the term `we' . . . was intended to emphasize that more than one investigator had requested the needed materials from Respondent.'' ALJ Ex. 24, at 4. However, the record fails to reflect this intent. \16\ I agree with the ALJ that it is possible, if not ``likely,'' that the DIs reviewed but ``may not have recognized Respondent's Exhibit V as an initial inventory because it contained far more information than would normally be contained in an initial inventory.'' R.D., at 17 n.20. --------------------------------------------------------------------------- For this reason, I disagree with the ALJ's statement that ``[t]here is a conflict in testimony concerning what the DEA investigators specifically asked for'' during the inspection because both the GS's and Respondent's testimony could be accurate. R.D., at 15 n.6. That is, the GS may be correct that DIs conducting inspections (``we'') typically ask registrants for DEA 222 forms, inventories, and dispensing logs. Tr. 103 (``[i]t's the same things we ask for every time''). Indeed, the GS has conducted over 400 audits in her more than 28 years with the DEA and had been a Group Supervisor for over six of those years, so she should know how DIs typically conduct audits. See id. at 25, 59; ALJ Ex. 24, at 4-5. Likewise, Respondent may also be correct in his recollection that, for his particular inspection, the DIs asked more generally for ``paperwork'' related to the Quintiles study. E.g., Tr. 212-13. Moreover, the same could be true for whether Respondent provided an initial inventory and dispensing log. Thus, the fact that the GS herself did not see or recognize these documents does not preclude the possibility that Respondent provided them to one of the other DIs at the inspection. Rather than reflecting a conflict, this testimony highlights a gap in the Government's evidence. The GS's testimony that DIs conducting inspections typically ask for DEA 222 forms, inventories, and dispensing records is insufficient to establish by a preponderance of the evidence that the lead DI asked for these documents in this particular case. The lead DI who the GS testified had made the requests for this paperwork (and who was most likely to have received the response) during the inspection did not testify at the hearing. Moreover, the Government did not offer as a witness the third DI present during the inspection to corroborate the GS's testimony.\17\ For these reasons, the record created by the Government is insufficient to establish by a preponderance of the evidence that Respondent failed to provide the DIs with what Respondent characterized as his initial inventory \18\ and dispensing logs during the July 9, 2014 inspection. --------------------------------------------------------------------------- \17\ The Government stated in its Exceptions that ``[t]he third investigator had been reassigned to another DEA field office.'' ALJ Ex. 24, at 4 n.4. However, nothing in the record explains why this reassignment precluded the third DI from testifying at the hearing. \18\ As discussed more fully infra, I also dismiss the Government's first recordkeeping charge regarding Respondent's initial inventory for legal reasons. --------------------------------------------------------------------------- And for the same reasons, I need not reach the credibility issue raised by the ALJ and the Government in its Exceptions of whether the GS's testimony was more credible than Respondent's testimony regarding the paperwork that the DIs requested and received from Respondent during the inspection. The ALJ found that the GS's testimony in this context (and others) lacked credibility because the ALJ found the GS's testimony in conflict with Respondent's testimony. R.D., at 3-4, 15 n.17, 17 n.20, 19 n.25, 21 n.28, 34. In its Exceptions, the Government disagreed with the ALJ's credibility findings and stated that, ``[a]ssuming the DEA investigator's testimony is accepted over Respondent's testimony, then it would be established that the initial inventory, dispensing records, and missing DEA-222 form were not provided to the investigators at the time of DEA's on-site visit and therefore DEA's allegations in the Order to Show Cause would be sustained.'' ALJ Ex. 24, at 2 n.3. However, and for the reasons already noted, even assuming arguendo that the GS's testimony was credible, it would be insufficient to establish by a preponderance of the evidence that Respondent failed to provide the DIs with an initial inventory or dispensing logs during their July 9, 2014 inspection. Inspection of Moore Clinical Trials Later the same say, after conducting their inspection of Respondent's registered location, the DIs went to Moore Clinical Trials. See Tr. 56. Although the GS and Respondent provide conflicting testimony regarding why Respondent directed the DIs to Moore Clinical Trials,\19\ the Government [[Page 47360]] offered the GS's testimony regarding the DIs visit there to establish the Show Cause Order's allegation that Respondent had improperly maintained his inventory or dispensing records at a location other than his registered location. Upon arriving at Moore Clinical Trials, the DIs spoke with Kianna Marshall, who was an assistant to Moore Clinical Trials owner Greta Moore. Id. at 56-57. The GS testified that the DIs asked Ms. Marshall for the inventory and dispensing log for the study so DEA ``could complete an accountability audit. And Kianna gave us a folder that had the dispensing records in it. However, she did not have any inventory.'' Id. at 57; see GX 11. --------------------------------------------------------------------------- \19\ The GS testified that Respondent directed the DIs to Moore Clinical Trials because that was where they could find records related to the study. Tr. 478-79. This testimony is consistent with Respondent's testimony that the DIs ``wanted my paperwork for the study.'' Id. at 213. After this point, however, the clarity ends. Respondent testified that the question of patient names and addresses came up and that he therefore referred the DIs to Moore Clinical Trials for paperwork more specifically related to patient names and addresses (the Quintiles Study precluded Respondent from knowing the patients' names). See id. at 279, 374. On rebuttal, the GS testified that the DIs went to Moore Clinical Trials because Respondent advised that he did not have in his office the records related to the study that they cared about--i.e., an initial inventory and dispensing records--at his registered location because they were at Moore Clinical Trials. Id. at 56 (``Upon learning that the dispensing records were at Moore Clinical Trials . . . [and a]fter our onsite inspection completed at Dr. Nichols, we went straight to Moore Clinical Trials . . . that same day . . . [T]he purpose of going to Moore Clinical Trials'' was ``to obtain the documents that Dr. Nichol told us was there, which would be inventory and the dispensing records''); see also id. at 478. The GS also rejected the notion that the DIs had any interest in the patients' names and addresses because the inspection was focused on drugs, not people. Id. at 478. The ALJ rejected the GS's explanation and found Respondent's ``more credible'' because (1) the stated purpose of the inspection was to ensure compliance with the MOA; (2) the inspection pursuant to the MOA focused on recordkeeping, not drugs; (3) Respondent had advised DEA by letter (to which DEA did not respond) in August 2012 that he could not provide patient names for a double blind study; and (4) the ALJ accepted that Respondent provided the DIs with Respondent's Exhibit U, which Respondent represented to be his dispensing log. R.D., at 15 n.16. Assuming that the purpose of the inspection was to determine whether Respondent's recordkeeping was in compliance with the MOA, the CSA, and DEA regulations, that purpose is consistent with the GS's explanation that the DIs' focus was on drugs and not patient names. The relevant recordkeeping requirements focus on tracking the movement of controlled substances (inventory, dispensing logs, DEA 222 forms), not the identity of patients. Moreover, as already noted, the more recent January 11, 2013 correspondence from DEA to Respondent prior to the inspection asked when the Quintiles study would commence and where the study drugs would be located (both of which relate to MOA requirements) and not the identity or addresses of Respondent's study patients. See RX R, at 3. Most importantly, I need not reach the question of whether the GS's explanation of why the DIs visited Moore Clinical Trials was more or less credible than Respondent's because, as discussed more fully infra, I reject the Government's charge that Respondent failed to maintain his inventory and dispensing records at his registered location. --------------------------------------------------------------------------- Respondent denied that he failed to maintain his inventory and dispensing records in his office because he represented that he kept them in his office and presented them to the DIs during the inspection. See Tr. 278-79; RX U; RX V. As already noted, the GS did not recall seeing (or saw but failed to recognize) the documents in Respondent's office as his inventory or dispensing records (RX U and RX V), and it is unclear what the other DIs understood because they did not testify. Importantly, the fact that Ms. Marshall provided the DIs with documents that she believed were responsive to the DIs' requests does not mean that those documents were, in fact, Respondent's dispensing records nor that Respondent intended to maintain his dispensing records at Moore Clinical Trials. Accord R.D., at 19 n.25 (``there is no credible evidence before me that [what Ms. Marshall provided to the DIs] is in fact, the Respondent's dispensing records''). Likewise, the fact that the GS believed that these documents could qualify as Respondent's dispensing records, or that Ms. Marshall may have advised the DIs that they were Respondent's dispensing records, is not dispositive of whether they were, in fact, what Respondent maintained as his dispensing records under the CSA and DEA's regulations. Accord id. Instead, I agree with the ALJ that the records provided by Ms. Marshall were more likely worksheets used as part of the Quintiles study to reconcile differences between what the study patients entered into their electronic monitors and the actual pill count. Id. at 20. Although the worksheets include all of the data in Respondent's dispensing log maintained in his office, the worksheets contain additional information not included in Respondent's dispensing log. Compare GX 11 with RX U.\20\ --------------------------------------------------------------------------- \20\ For this reason, the Government's claim that it could not complete an accountability audit at Respondent's registered address is unavailing. The worksheets obtained from Moore Clinical Trials included everything contained in the dispensing logs maintained in Respondent's office, which was sufficient to complete the audit. See Tr. 484. The GS testified that the DIs had difficulty using the worksheets because ``[t]here are numerous cross-outs and circles and initials and changing of dates . . . it's very hard to determine what's coming in and what's going out.'' Tr. 59. However, the GS conceded that having cross-outs or even confusing records does not violate DEA regulations, and they ultimately did not preclude the DIs from completing their audit. Id. at 69-70. --------------------------------------------------------------------------- Neither the Government nor Respondent called Ms. Marshall as a witness to establish what Respondent may have told her about maintaining his dispensing records at Moore Clinical Trials or what she believed she had provided to the DIs. Thus, I find that the Government has provided insufficient evidence for me to find by a preponderance of the evidence that Respondent, in fact, failed to maintain inventory and dispensing records at his registered location. Respondent's DEA 222 Forms The GS testified that DEA 222 forms are three-part forms that DEA registrants use to order controlled substances. See Tr. 38, 42. Registrants request a book of DEA 222 forms in advance of ordering controlled substances, and then DEA sends back a book of DEA 222 forms--each one preprinted with the registrant's name, DEA registration number, the date he or she ordered the forms, and the schedules for which he or she is authorized to prescribe. See id. at 43-44. These forms have carbon paper in between each copy so three parties can each get a copy. Id. at 38, 42. ``One is the purchaser's copy, one is the supplier's copy, and the third copy goes to DEA once the order is completed.'' Id. at 44-45. The GS testified that ``[Respondent] or his representatives fills out the supplier name, the date, and the requested drugs. And he tears off that first copy, the purchaser's copy. He holds onto that. And then the second two copies, the DEA copy and the supplier copy, get sent to the supplier.'' Id. at 45. When Respondent is placing an order, he retains the copy that states ``PURCHASER'S Copy 3.'' Id.; e.g., GX 9; RX S, at 5, 9-12, 16. For example, the DEA 222 forms that Respondent provided to the DIs during their inspection show that Fisher Clinical Services (FCS) was the supplier of the drugs Respondent used in the study. Id. When Respondent ``is shipping drugs back to his supplier, Fisher [Clinical] Services,'' then his name would appear on the DEA 222 form as the supplier, FCS would be the registrant, and Respondent would retain ``SUPPLIER'S Copy 1.'' Tr. 48-50; GX 10; RX S, at 13-14. When filling out a supplier's copy, the supplier must fill out several fields on the form, including the number of packages, the size of the packages, the packages shipped, and the date when they were shipped. Tr. 50; GX 10; RX S, at 13-14. Respondent's Annotation of DEA 222 Forms In this case, Respondent provided DEA with two DEA 222 forms in which he was the ``supplier'' and FCS was the registrant because he was returning unused drugs from the clinical trial back to FCS. Tr. 48-50, 253-54; see also GX 10; RX S, at 13-14. FCS had provided Respondent with a packing list that included instructions on how to fill out the DEA 222 forms as the supplier, including instructions that he should enter the number of kits shipped and the date shipped. RX S, at 15; Tr. 376-77. However, Respondent left the ``Packages Shipped'' and ``Date Shipped'' boxes next to the identified kits blank in both DEA 222 forms in which Respondent was the supplier. RX S, at 15; Tr. 50. As a result, the GS testified that when these boxes are left blank, DEA ``do[es] not know if th[e kits are] indeed what Dr. Nichol shipped back.'' Tr. 50. This negatively impacts DEA's ability to conduct an audit of a registrant, according to the GS, ``because the DEA 222 order form is a primary record . . . as far as auditing purposes, these are the only documents we are supposed to look at.'' Id. at 51. In his testimony, Respondent admitted that he failed to properly annotate the ``Packages Shipped'' and Date Shipped'' boxes: Q . . . Now, as you're sitting here today, do you realize that you completed this [first 222] form that you left off a date and the packets that were shipped back? A Yes sir, I did. . . . Q . . . So at least what [the GS] said about the return of this 222 form, that was correct, what she said; is that right? [[Page 47361]] A Yes. . . . I did not fill out the date and I did not fill out the package quantity. Tr. 256-57; see also id. at 258 (``Q Okay. And again you made the same clerical error on that [second 222] form? A I did.''). Accordingly, I find that Respondent failed to properly annotate two DEA 222 supplier's copy forms set forth in Government's Exhibit 10 because he failed to complete the ``Packaged Shipped'' and Date Shipped'' entries. GX 10; RX S, at 13-14.\21\ --------------------------------------------------------------------------- \21\ During the hearing, the GS also testified to recordkeeping errors made by Respondent in filling out the purchaser's copies of the DEA 222 forms. See, e.g., Tr. 47-48 (Respondent improperly used three lines to order one drug when ``[t]he regulations state that when you are ordering a drug, it's one drug per line''). She stated that Respondent's failure to accurately complete the initial DEA 222 forms caused accountability errors in the audit. Id. at 488. The Government did not, however, allege these errors in its Show Cause Order or Prehearing Statements. Thus, I agree with the ALJ's recommendation not to consider this evidence in determining the sanction in this case. R.D., at 3 n.2. --------------------------------------------------------------------------- Respondent's Allegedly Missing DEA 222 Form In its Show Cause Order, the Government alleged that Respondent failed during the onsite inspection to provide a January 16, 2014 DEA 222 form.\22\ ALJ Ex. 1, at 3. On the first day of the hearing, the GS testified that Respondent ``produced for . . . inspection'' ``five DEA 222 order forms for purchase'' and ``two DEA order forms for returns back to the supplier,'' and that Government Exhibits 9 and 10 included copies of these seven forms. See Tr. 39, 40-41, 52, 56 (``the only thing we received were a grand total of seven completed DEA form 222s''); GXs 9-10. These exhibits did not include Respondent's purchaser's copy of the January 16, 2014 DEA 222 form. In addition, the GS testified that they did not ask Respondent why there were only five purchaser DEA 222 forms and not six such forms--even though the DIs knew that Respondent had made six orders of controlled substances when they arrived for the onsite inspection. Tr. 76, 505-06. Respondent testified that, had the DIs advised him that he was missing any records, he would have endeavored to find and to provide them to the DIs. Id. at 236. --------------------------------------------------------------------------- \22\ As noted supra in footnote 2, the Show Cause Order erroneously referenced an August 28, 2013 DEA 222 form. The Government corrected the date of the allegedly missing DEA 222 form to January 16, 2014 in its May 12, 2016 Prehearing Statement and during Government counsel's Opening Statement at the administrative hearing. See ALJ Ex. 7, at 8; Tr. 15. I further note that January 16, 2014 represents the shipping date, not the January 13, 2014 date on which Respondent actually ordered the controlled substances. See GX 13, at 1; RX S, at 16. --------------------------------------------------------------------------- Although her testimony was not always clear on this subject, the GS ultimately testified on rebuttal that Respondent (or someone in his office) ``presented'' to the DIs ``a folder with all of the 222s.'' Tr. 507; see also id. at 290-91 (Respondent testified that ``[t]he DEA 222s were kept in a hanging file folder in a safe next to my office--or in my office in a safe next to my desk. . . . [Respondent] provide[d] that folder to the DEA investigators on the date of the onsite inspection.''). Also during rebuttal, the GS acknowledged that Respondent had provided a folder to the DIs that not only included completed DEA 222 forms reflected in Government Exhibits 9 and 10 but also included ``voided and unused DEA 222s.'' Id. at 475. The GS stated that she was uninterested in the ``voided out and unused DEA 222s'' and therefore only obtained ``copies of the [completed] 222 order forms that were within our audit'' period. Id. Respondent introduced Respondent's Exhibit S, which the ALJ accepted into evidence as the contents of the entire folder of DEA 222 forms (22 pages) that Respondent provided to the DIs during the onsite inspection. See Tr. 214-15; RX S. The exhibit included unused, voided, and completed DEA 222 forms (both Purchaser's Copies and Supplier's Copies) as well as a completed DEA 222 form from a previous drug study. Tr. 261, 475; RX S. Most significantly, Respondent's exhibit included a copy of the allegedly missing DEA 222 form related to the January 16, 2014 controlled substances shipment to Respondent. RX S, at 16. The GS did not recall seeing that form, and Respondent did not recall to which DI he gave the folder. Tr. 291 (``Q Do you [Respondent] remember which agent you gave these to? A ``I do not.''); id. at 475. After the pending Show Cause Order was served on Respondent, Respondent telephoned Mathilda Buchanan, an Arkansas-licensed private investigator with whom Respondent had worked since 2006. Tr. 262, 417. Respondent provided the same folder of DEA 222 forms (Respondent's Exhibit S) to Ms. Buchanan that he had provided to the DIs. See id. at 262. When Ms. Buchanan examined the contents of the folder, she testified that she discovered that the allegedly missing purchaser's copy of January 2014 DEA 222 form was in fact within the folder but stuck between unused DEA 222 forms. Id. at 452-53, 462; RX S, at 16. Moreover, the DEA 222 form that Ms. Buchanan found was a purchaser's copy for an order of controlled substances dated January 13, 2014, which corresponded to the January 16, 2014 shipment of controlled substances to Respondent reflected on the supplier's copy submitted into evidence by the Government. See Tr. 260; GX 13, at 1; RX S, at 16. The ALJ recommended that I make the fact finding that the January 16, 2014 DEA 222 form ``was available to the DEA investigators during the inspection'' and that ``[i]t is highly probable that the alleged missing 222 Form was caught up in the carbon copies of the other 222 Forms contained in the folder where the Respondent kept his records.'' R.D., at 22, 34. In other words, the ALJ believed that the DIs simply overlooked the January 16, 2014 DEA 222 form during the onsite inspection. Id. at 34. I agree, and I find that it is more likely than not that the purchaser's copy of the January 2014 DEA 222 form was indeed in Respondent's folder of DEA 222 forms on the date of the onsite inspection.\23\ --------------------------------------------------------------------------- \23\ For the same reason, I again need not reach the question of the GS's credibility regarding the allegedly missing DEA 222 form raised by the ALJ in his Recommended Decision and the Government in its Exceptions. R.D., at 34; ALJ Ex. 24, at 2 n.3, 5. Specifically, because I find (as did the ALJ) that the DIs overlooked the DEA 222 form in question, the GS could credibly testify that she did not see the form during the onsite inspection. Likewise, Ms. Buchanan could credibly testify that her (apparently more thorough) review of the folder of DEA 222 forms did uncover the allegedly missing form. Accordingly, I find that there is no credibility issue regarding the allegedly missing DEA 222 form because it is more likely than not that the testimony of both witnesses is accurate. --------------------------------------------------------------------------- The December 2014 Meeting In December 2014, the lead DI contacted Respondent to set up a meeting with him. Tr. 237. This was the first time the DIs had contacted Respondent since the July 9, 2014 onsite inspection. See id. On December 16, 2014, two DIs--the GS and the lead DI--met with Respondent and Ms. Buchanan ``to report on the July 9, 2014 inspection.'' ALJ Ex. 9, at 3; Tr. 481. During the meeting, the DIs advised Respondent that his ``inventory was off.'' Tr. 237. Respondent stated that he offered to compare his inventory with DEA's inventory, but the DIs refused. Id. at 238, 437, 507-08. The DIs also discussed the accuracy of Respondent's dispensing records and that Respondent had failed to provide the DIs with sufficient information to complete a proper audit, which in turn required the DIs to go to Moore Clinical Trials to supplement the information. Id. at 439, 461. The DIs did not ask Respondent for any records during the meeting. Id. at 500. On December 19, 2014, Respondent's attorney wrote a letter to the lead DI and to the GS on behalf of Respondent in response to the December 16, 2014 [[Page 47362]] meeting. RX X. The letter memorialized Respondent's understanding that DEA's ``audit was not available to us'' and asked for ``written documentation of specific points you think are lacking so we can do better.'' Id. The letter also stated that records related to the identification of patients ``must be kept at Moore Clinical Trials and are separate from the records at Dr. Nichol's office which only contain the patients' identifying numbers.'' Id. Respondent never received a reply to his attorney's letter, and the Government filed its Show Cause Order on March 14, 2016. Tr. 443; ALJ Ex. 1. Discussion Under the Controlled Substances Act (``CSA''), ``[a] registration pursuant to section 823 of this title to manufacture, distribute, or dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant . . . has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.'' 21 U.S.C. 824(a)(4). In the case of a physician, who is deemed to be a practitioner, see id. Sec. 802(21), Congress directed the Attorney General to consider the following factors in making the public interest determination: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing or conducting research with respect to controlled substances. (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. Sec. 823(f). ``[T]hese factors are . . . considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that I ``may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether'' an application for registration should be denied. Id.; see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while I am required to consider each of the factors, I ``need not make explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482.\24\ --------------------------------------------------------------------------- \24\ In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's or applicant's misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, findings under a single factor can support the revocation or suspension of a registration. MacKay, 664 F.3d at 821. --------------------------------------------------------------------------- Under the Agency's regulation, ``[a]t any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to . . . 21 U.S.C. [Sec. ]824(a) . . . are satisfied.'' 21 CFR 1301.44(e). In this matter, I have considered all of the factors and concluded that the Government's evidence with respect to Factors Two and Four support the conclusion that Respondent has committed acts which render his ``registration inconsistent with the public interest.'' 21 U.S.C. 823(f), 824(a)(4). While I agree with the ALJ's conclusion that a sanction is appropriate, I find that the record supports a stronger sanction than what the ALJ recommended. Factor One--The Recommendation of the State Licensing Authority The Government sought to revoke Respondent's DEA registration based on Factors Two, Four, and Five. However, the ALJ considered Factor One as well in his Recommendation. R.D., at 27. I agree with the ALJ's finding that the ASMB has not made a recommendation to the Agency regarding whether Respondent's DEA registration should be suspended or revoked in this case. See id. The record only shows that the ASMB suspended Respondent's state medical license for six months based on his pre-signing of controlled substance prescriptions, which his staff (who were not licensed to prescribe controlled substances) issued to patients outside Respondent's presence and without consulting him. The ALJ noted that the ASMB reinstated Respondent's medical license after six months and stated that ``[t]he reinstatement of the Respondent's medical license can be interpreted as a recommendation of the ASMB'' under Factor One. R.D., at 27 (citing Tyson D. Quy, M.D., 78 FR 47412, 47417 (2013); Vincent J. Scolaro, D.O., 67 FR 42060, 42064-65 (2002)). As a result, the ALJ recommended that I find that ``the ASMB's reinstatement of the Respondent's medical license only weighs slightly in favor of not revoking the Respondent's registration.'' R.D., at 28. To be sure, the Agency's case law contains some older decisions which can be read as giving more than nominal weight in the public interest determination to a State Board's decision (not involving a recommendation to DEA) either restoring or maintaining a practitioner's state authority to dispense controlled substances. See, e.g., Gregory D. Owens, 67 FR 50461, 50463 (2002) (expressing agreement with ALJ's conclusion that the Board's placing dentist on probation instead of suspending or limiting his controlled substance authority ``reflects favorably upon [his] retaining his . . . [r]egistration, and upon DEA's granting of [his] pending renewal application''); Scolaro, 67 FR at 42065 (concurring with ALJ's ``conclusion that'' state board's reinstatement of medical license ``with restrictions'' established that ``[b]oard implicitly agrees that the [r]espondent is ready to maintain a DEA registration upon the terms set forth in'' its order). However, these cases cannot be squared with the Agency's longstanding holding that ``[t]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.'' Garrett Howard Smith, M.D., 83 FR 18882, 18904 n.30 (2018) (quoting Mortimer Levin, 57 FR 8680, 8681 (1992)); Lon F. Alexander, M.D., 82 FR 49704, 49724 n.42 (2017) (same). Indeed, neither Owens nor Scolaro even acknowledged the existence of Levin, let alone attempted to reconcile the weight it gave the state board's action with Levin. Smith, 83 FR at 18904 n.30; Alexander, 82 FR at 49724 n.42. While in other cases, the Agency has given some weight to a Board's action in allowing a practitioner to retain his state authority even in the absence of an express recommendation, see Quy, 78 FR at 47417, the Agency has repeatedly held that a practitioner's retention of his or her state authority is not dispositive of the public interest inquiry. See, e.g., Smith, 83 FR at 18904 n.30; Alexander, 82 FR at 49724 n.42; Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)). Accordingly, I find that the ASMB's reinstatement of Respondent's state license is not dispositive of the public [[Page 47363]] interest inquiry in this case, and I give it no weight.\25\ --------------------------------------------------------------------------- \25\ As to Factor Three, there is no evidence that Respondent has been convicted of an offense under either federal or Arkansas law ``relating to the manufacture, distribution or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d at 822. The Agency has therefore held that ``the absence of such a conviction is of considerably less consequence in the public interest inquiry'' and is therefore not dispositive. Id. --------------------------------------------------------------------------- Factors Two and Four--The Respondent's Experience in Dispensing Controlled Substances, or Conducting Research With Respect to Controlled Substances, and Compliance With Applicable Laws Related to Controlled Substances Pre-Signed Prescriptions Allegation The Show Cause Order's first charge alleged that Respondent's pre- signing of prescriptions for controlled substances violated 21 CFR 1306.05(a). Under the CSA, it is ``unlawful for any person [to] knowingly or intentionally . . . manufacture, distribute, or dispense,\26\ or possess with intent to manufacture, distribute, or dispense, a controlled substance'' ``[e]xcept as authorized by'' the Act. 21 U.S.C. 841(a)(1). According to the CSA's implementing regulations, ``[a]ll prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.'' 21 CFR 1306.05(a). --------------------------------------------------------------------------- \26\ ``The term `dispense' means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing . . . of a controlled substance.'' 21 U.S.C. 802(10). --------------------------------------------------------------------------- The Agency has long held that pre-signing prescriptions violates the CSA and 21 CFR 1306.05(a). Arvinder Singh, M.D., 81 FR 8247, 8248 (2016); Alvin Darby, M.D., 75 FR 26993, 26999 (2010) (``DEA has long interpreted the CSA as prohibiting the pre-signing of prescriptions.''); Jayam Krishna-Iyer, M.D., 71 FR 52148, 52158, 52159 n.9 (2006) (``Respondent further violated federal law and DEA regulations by giving [his nurse] pre-signed prescriptions and allowing him to issue them to a patient [Respondent] had not attended to. . . . [T]his conduct of Respondent violated 21 CFR 1306.05(a)''), vacated on other grounds, 249 Fed. Appx. 159 (11th Cir. 2007); Leslie, 68 FR at 15230-31; James Beale, 53 FR 15149, 15150 (1988) (``It is a violation of 21 CFR 1306.05(a) to pre-sign prescriptions for controlled substances.''). Most importantly, the Agency has held that pre-signing prescriptions ``would be inconsistent with the public interest'' under the CSA because such conduct ``create[s] a substantial risk that the drugs would be diverted and abused.'' Singh, 81 FR at 8248, 8249. As noted earlier, it is undisputed that on August 17, 2016, the ASMB issued a final order suspending Respondent's medical license for six months because he pre-signed prescriptions for controlled substances. During the ASMB hearing leading up to its final order, Respondent admitted in testimony that he pre-signed prescriptions in which he failed to write the name of the patient on the prescription, the substance prescribed, and instructions for taking the medication. In addition, Respondent admitted during the ASMB hearing that he permitted his office personnel, who were not licensed as physicians nor authorized to prescribe medications under Arkansas law, to fill in the blanks on the prescription pad and distribute them to patients without Respondent being present. Thus, I agree with the ALJ's recommendation that I find (and I do so find) that Respondent's pre-signing of prescriptions violated 21 CFR 1306.05(a). I also find that this conduct constituted a serious violation of the CSA and created a substantial risk that the drugs would be diverted and abused. Krishna-Iyer, 71 FR at 52159; Singh, 81 FR at 8249. I further find that Respondent violated federal law by giving the pre-signed prescription forms to office personnel who lacked the authority to lawfully prescribe controlled substances under federal or state law. See 21 CFR 1306.03(a); see also Krishna-Iyer, 71 FR at 52159. Accordingly, the Government's first charge of pre-signing prescriptions is sustained and supports a finding that Respondent's continued registration would be inconsistent with the public interest. Recordkeeping Allegations The Show Cause Order sets forth five recordkeeping charges based on DEA's July 4, 2014 on-site inspection of Respondent's registered location. ``Recordkeeping is one of the CSA's central features; a registrant's accurate and diligent adherence to this obligation is absolutely essential to protect against the diversion of controlled substances.'' Paul H. Volkman, 73 FR 30630, 30644 (2008). As the Agency recently held: [T]he CSA and DEA regulations require that a registrant take an actual physical count of the controlled substances on hand, and an accurate actual count, as memorialized in either an initial or biennial inventory[. This] is essential in conducting an accurate audit. Likewise, an accurate audit is essential in determining whether a registrant is maintaining complete and accurate records of both the controlled substances he receives and those he ``deliver[s] or otherwise dispose[s] of.'' 21 U.S.C. 827(a)(3). . . . [G]enerally, it is diversion that results in recordkeeping irregularities and not the other way around. Peter F. Kelly, D.P.M., 82 FR 28676, 28692 n.41 (2017), pet. for rev. denied, Kelly v. DEA, No. 17-1175, 2018 WL 3198774 (D.C. Cir. May 18, 2018). The Show Cause Order's first recordkeeping charge alleged that Respondent failed to maintain an initial inventory of all controlled substances ``in violation of 21 U.S.C. 827(a)(3) & 842(a)(5) and 21 CFR 1304.11(b).'' ALJ Ex. 1, at 2. As a threshold matter, the ALJ correctly noted ``that it appears that the Government made an error because Sec. 827(a)(3) requires a registrant to maintain a dispensing record'' and not an initial inventory as Sec. 827(a)(1) requires. See R.D., at 31 n.34. The ALJ also noted accurately that the ``Government, however, also correctly cites to 21 CFR 1304.11(b).'' Id. Section 1304.11(b) states that ``[e]very person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances.'' Thus, I agree with the ALJ that the Government intended to charge Respondent with failing to maintain an initial inventory, despite its reference to Sec. 827(a)(3) instead of Sec. 827(a)(1), and I further find that Respondent had adequate notice of this charge. Most importantly, the CSA and DEA's regulations only require a practitioner like Respondent to maintain an initial inventory when he ``first engages in . . . dispensing controlled substances.'' 21 CFR 1304.11(b); 21 U.S.C. 827(a)(1). ``After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years''--that is, a ``biennial inventory.'' 21 CFR 1304.11(c); accord 21 U.S.C. 827(a)(1). Thus, the CSA and DEA's regulations only required Respondent to maintain an initial inventory when Respondent first engaged in dispensing controlled substances after obtaining his DEA registration, even if the initial inventory was zero when Respondent ``commence[d] business.'' 21 CFR 1304.11(b). After that, the CSA and DEA regulations required Respondent to [[Page 47364]] maintain a biennial inventory. 21 U.S.C. 827(a)(1); 21 CFR 1304.11(c). Here, the Government's first recordkeeping charge cannot be sustained as a matter of law because Respondent was not legally required to maintain an initial inventory as of the date of the alleged violation--i.e., at the time of the July 9, 2014 inspection. It is undisputed that Respondent was dispensing controlled substances at least as far back as 2006 under his current DEA registration, and that Respondent has maintained, and timely renewed, his DEA registration ever since. Although the CSA and DEA regulations required Respondent to maintain an initial inventory when he first commenced the business of dispensing controlled substances under his current DEA registration for two years, he was only required to maintain a biennial inventory thereafter. Yet the Government's first recordkeeping charge centers on whether Respondent maintained an initial inventory when he ordered controlled substances in December 2012, not on when Respondent first ``commence[d the] business'' of dispensing controlled substances under his current DEA registration. Thus, even if Respondent began dispensing controlled substances for the first time as late as 2006--the earliest dispensing activity under Respondent's current DEA registration reflected in the record--he had no legal obligation to maintain an initial inventory beyond 2008. Instead, as already noted, he was legally obligated to maintain a biennial inventory thereafter. However, the Government did not charge Respondent with failing to maintain an accurate biennial inventory in December 2012 or at the time of the July 2014 inspection. Accordingly, I do not sustain the Government's first recordkeeping charge.\27\ --------------------------------------------------------------------------- \27\ In any event, as noted supra, I found that the Government failed to establish by a preponderance of the evidence that Respondent failed to provide the DIs with an inventory consistent with the CSA and DEA's regulations during the July 9, 2014 onsite inspection. --------------------------------------------------------------------------- The Government's second recordkeeping charge alleged that Respondent failed to provide dispensing records to the DIs during the July 9, 2014 inspection. Both the CSA and DEA regulations require registrants to ``maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold . . . or otherwise disposed of by him.'' 21 U.S.C. 827(a)(3); 21 CFR 1304.21(a). As found above, supra, the Government failed to establish by a preponderance of the evidence that Respondent failed to provide the DIs with the relevant dispensing logs during the inspection. Furthermore, I agree with the ALJ's recommended finding (and I so find) that the dispensing log that Respondent testified that he provided to the DIs (RX U) was sufficient to rebut the Government's allegation that he failed to maintain complete and accurate dispensing records in violation of 21 U.S.C. 827(a)(3), 842(a)(5) and 21 CFR 1304.21(a). See R.D., at 32-33. Thus, I do not sustain the Government's second recordkeeping charge. For related reasons, I cannot sustain the Government's fifth recordkeeping charge that Respondent failed to maintain his inventory and dispensing records at his registered location and maintained them instead at Moore Clinical Trials. The CSA requires that registrants maintain ``[a] separate registration . . . at each principal place of business or professional practice where the applicant . . . dispenses controlled substances.'' 21 U.S.C. 822(e). ``In short, the requirements that a practitioner be registered at each principal place of professional practice where he dispenses controlled substances . . . [is one] of the fundamental features of the closed regulatory system created by the CSA.'' Moore Clinical Trials, 79 FR at 40155. However, as found above, the Government has provided insufficient evidence for me to find by a preponderance of the evidence that Respondent, in fact, (1) maintained his dispensing records at Moore Clinical Trials and (2) failed to maintain inventory and dispensing records at his registered location.\28\ See supra. Thus, I agree with the ALJ's recommendation that I find (and I do so find) that the Government failed to sustain the fifth recordkeeping charge. See R.D., at 36. --------------------------------------------------------------------------- \28\ The Government also alleged in its fifth recordkeeping charge that Respondent's inventory and dispensing records were not ``readily retrievable'' pursuant to 21 CFR 1304.04. Section 1304.04(g) requires registered individual practitioners like Respondent to keep ``records of controlled substances in the manner prescribed in paragraph (f) of this section.'' Section 1304.04(f), in turn, requires that ``records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.'' Here, the controlled substance used during the Quintiles study was oxycodone, a Schedule II controlled substance. 21 CFR 1308.12(b)(1)(xiii). --------------------------------------------------------------------------- The Government's third recordkeeping charge alleged that Respondent failed to provide a January 2014 DEA 222 form during the inspection. DEA regulation 21 CFR 1305.17(a) requires the purchaser of controlled substances to ``retain Copy 3 of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.'' See also 21 CFR 1304.04(a) (requiring registrants to keep dispensing records and every inventory for at least two years). However, here too, I have already found that the Government's evidence is insufficient to support this charge. Specifically, I found supra that it is more likely than not that the purchaser's copy of the allegedly missing January 2014 DEA 222 form was, in fact, within Respondent's folder of DEA 222 forms that he presented to the DIs on the date of the onsite inspection. Thus, I do not sustain the Government's third recordkeeping charge. The Government's remaining (fourth) recordkeeping charge alleged that Respondent failed to properly annotate two DEA-222 order forms (dated August 15, 2013 and June 24, 2014) in violation of 21 U.S.C. 842(a)(5) and 21 CFR 1305.13(b). The DEA 222 forms at issue in the fourth recordkeeping charge were suppliers' copies, and DEA regulations require suppliers to ``record on Copies 1 and 2 [of the DEA 222 form] the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser.'' 21 CFR 1305.13(b). Here, as already noted, Respondent admitted that he failed to properly annotate on both forms (1) the date when he shipped controlled substances back to FCS and (2) the amount shipped. Accordingly, I find that the Government sustained its fourth recordkeeping charge that Respondent failed to properly annotate two DEA 222 supplier's copy forms pursuant to 21 U.S.C. 842(a)(5) and 21 CFR 1305.13(b). These violations support a finding that Respondent's continued registration would be inconsistent with the public interest under Factors Two and Four. Factor Five--Other Conduct Which May Threaten the Public Health and Safety The Government argues that Respondent engaged in ``other conduct'' actionable under Factor Five because he violated the MOA.\29\ Under the fifth [[Page 47365]] public interest factor, the Agency considers ``[s]uch other conduct which may threaten the public health and safety.'' 21 U.S.C. 823(f)(5). The Agency has clarified that Congress' use of the word ``may'' in Factor Five means that it intended the Agency to consider conduct which creates a probable or possible (and not necessarily an actual) threat to public health and safety. Mark P. Koch, D.O., 79 FR 18714, 18735 (2014) (collecting cases); ChipRX, L.L.C., d/b/a City Center Pharmacy, 82 FR 51433, 51438 n.10 (2017) (``Factor Five does not require that the Government prove an actual threat to public health or safety''). Thus, the Government is not required to establish that a specific violation of the MOA by Respondent created an actual threat to the health and safety of the public under Factor Five. --------------------------------------------------------------------------- \29\ The Government also argued that Respondent's alleged violations of the MOA should be considered under Factor 2. ALJ Ex. 20, at 19. In addition, the Agency has held that ``where an MOA term imposes the same requirements as a law or regulation, a violation of that term falls under Factor Four because it is also a violation of a duly enacted law or regulation.'' Roberto Zayas, M.D., 82 FR 21410, 21422 n.26 (2017). To the extent that I have already addressed Respondent's alleged recordkeeping violations under Factors Two and Four, I will not consider them again under Factor Five because they would not then constitute ``other conduct'' under Factor Five. See id. at 21427 n.40. However, I will consider whether the proved recordkeeping violations already discussed are sufficient evidence to establish a violation of the MOA under Factor Five. --------------------------------------------------------------------------- DEA has long held that a registrant's failure to comply with the terms of an MOA can constitute acts which render his registration inconsistent with the public interest. Erwin E. Feldman, D.O., 76 FR 16835, 16838 (2011) (revoking practitioner's registration under Factors Two and Five for violating MOA) (internal citation omitted); cf. Fredal Pharmacy, 55 FR 53592, 53593 (1990) (revoking pharmacy's registration for violations of its MOA ``which threatens the public health and safety''). This is so even if the violation of the MOA does not establish a violation of the CSA or its implementing regulations. Feldman, 76 FR at 16838. In its Proposed Findings of Fact and Conclusions of Law, the Government argued that this case is similar to OTC Distribution Company, where the Agency revoked the registration of a distributor for ``its inability or unwillingness to fully comply with its recordkeeping and report obligations under the MOA.'' ALJ Ex. 20 at 20-21 (quoting OTC Distribution Company, 68 FR 70538, 70542 (2003)). The Government further argued that, ``[a]s in OTC, the Respondent here has demonstrated, over a period of years, an unwillingness or inability to follow DEA's recordkeeping requirements even after being placed under an MOA with strict monitoring requirements.'' ALJ Ex. 20 at 21.\30\ --------------------------------------------------------------------------- \30\ In his Recommendation, the ALJ disagreed with the Government's characterization of Respondent's past recordkeeping conduct because ``the Respondent does not have a history of failing to keep the required records.'' R.D., at 39. However, as discussed more fully infra, Respondent's history of recordkeeping violations is already documented in published Agency precedent. See, e.g., Moore Clinical Trials, 79 FR at 40151, 40155. --------------------------------------------------------------------------- Indeed, the history of Respondent's recordkeeping violations (and other violations) directly led to the MOA that attempted to resolve them. As I already noted supra, the GS testified that DEA first became aware of Respondent as part of its 2011 investigation of his recordkeeping (and other) violations regarding the earlier NKRT-118 study he conducted with Moore Clinical Trials. Tr. 28-29. This 2011 investigation not only led to the 2011 Show Cause Order against Respondent; it also led to a separate 2011 Show Cause Order against Moore Clinical Trials. However, unlike Respondent, who resolved the Show Cause Order against him by entering into an MOA, the Order against Moore Clinical Trials resulted in a final published order. Moore Clinical Trials, L.L.C., 79 FR 40145 (2014). Most importantly, in Moore Clinical Trials, the Agency found that Respondent committed recordkeeping and other violations related to the NKRT-118 study that correspond to the terms of the MOA. For example, the Agency noted the ALJ's findings that Respondent's ``documents'' ``were deficient and that the order forms for Schedule II controlled substances (DEA-222) were lacking'' in connection with the NKRT-118 study. Id. at 40147 (internal quotations omitted). The Agency also noted the ALJ's finding that Respondent had improperly transported controlled substances to Moore Clinical Trials' location where he was not registered to dispense them in connection with that study. Id. The then-Administrator also found that Respondent's DEA 222 forms related to the NKRT-118 study did not properly indicate the date the drugs were received and the quantity received. Id. at 40151, 40156. The then- Administrator concluded that ``the record clearly establishes that Dr. Nichol violated both the separate registration provision and DEA recordkeeping requirements.'' Id. at 40155. The DEA therefore entered into the MOA (which expressly referenced the NKRT-118 study) with Respondent as an intermediary step to get Respondent into compliance and to address Respondent's recordkeeping and separate registration violations related to the NKRT-118 study described and found by the Agency in Moore Clinical Trials.\31\ --------------------------------------------------------------------------- \31\ See supra footnote 12. --------------------------------------------------------------------------- Respondent agreed to meet the following seven conditions set forth in the MOA: (1) Abide by all Federal, State and local statutes and regulations relating to controlled substances. (2) Make and keep (and make available for inspection) records of all controlled substances that he prescribes, dispenses, and administers at his registered location pursuant to 21 CFR 1306.05(a) and 1304.21. (3) Make and keep a legible log of all Schedule II-V controlled substances that he prescribed and provide that to DEA on a quarterly basis for three years. (4) Retain his prescribing, administering and dispensing records at his registered location. (5) Notify DEA if he will prescribe, dispense, or administer controlled substances at any location other than his registered location or the Springhill Surgery Center where he routinely administers drugs during a scheduled medical procedure. (6) Order, receive, administer, and dispense controlled substances only at his registered location. (7) Notify DEA in advance of commencing any drug study involving controlled substances additional to the NKTR-118 study. GX 7, at 2-4. It is undisputed that Respondent did not violate the MOA's third and fifth conditions. See Tr. 92, 93, 117-19. The Government argued that the same five alleged recordkeeping violations also violated the MOA's first, second, fourth, and sixth conditions.\32\ See R.D., [[Page 47366]] at 40; Tr. 91-93, 178-79. I discussed all of the recordkeeping allegations in my analysis of Factors Two and Four, wherein I concluded that the Government proved only one recordkeeping violation by a preponderance of the evidence--Respondent's failure to properly annotate two supplier DEA 222 forms. With respect to Factor Five, I also find that these two recordkeeping failures violated the MOA's first condition that Respondent abide by all Federal regulations because (as already noted) failing to properly annotate a supplier's DEA 222 form violates 21 CFR 1305.13(b). Thus, I agree with the ALJ's recommendation that I find (and I do find) that Respondent violated the MOA based on his failure to properly annotate two supplier DEA 222 forms. R.D., at 40. --------------------------------------------------------------------------- \32\ During the hearing, the Government alleged that Respondent violated the MOA's seventh condition for failing to notify DEA in advance of commencing the Quintiles Study set forth in the CTA. See Tr. 93-94, 119-21, 181-82; GX 7, at 3 (``if [Respondent] is asked to participate in additional drug studies involving controlled substances, he will notify DEA in advance of commencing the study''). Although the ALJ questioned whether the Government had provided sufficient notice to Respondent that the Government would rely on a violation of this MOA condition, the ALJ proceeded to analyze the issue and recommended that I find that Respondent did not violate this MOA condition. See R.D., at 10 n.11. I agree (and I do so find) that Respondent did not violate this MOA condition for the following reasons. Although the GS testified that ``[i]n DEA's mind'' the study commenced when Respondent placed his first order for controlled substances related to the study on December 3, 2012 (Tr. 93-94, 121), the Government has identified no provision of the CSA, DEA's regulations or Agency precedent supporting this statement. Moreover, the MOA did not define what constituted ``commencing the study.'' Absent additional evidence of the parties' intent when entering into the MOA, I find that the Quintiles Study commenced when Respondent first dispensed controlled substances. If, hypothetically, Respondent had ordered and received controlled substances for the Quintiles Study, enrolled study patients for it, but never ultimately dispensed the controlled substances to the enrolled study patients, then the study still would not have commenced. Here, on December 31, 2012, Respondent notified the GS (by letter from his attorney) that he was participating in the study. As noted supra, I found that Respondent began enrolling patients for the Quintiles study in January 2013, and that he first dispensed controlled substances to study patients on February 18, 2013. Thus, I find that Respondent did not violate the MOA's seventh condition because he notified DEA that he was asked to participate in the Quintiles Study on December 31, 2012, in advance of commencing the study on February 18, 2013. --------------------------------------------------------------------------- I also agree with the ALJ's recommendation that the analysis of whether the MOA violation was sufficient to establish a violation of Factor Five does not stop here. Under the MOA, Respondent agreed that ``any violations of the Agreement may result in the initiation of proceedings to revoke or immediately suspend and revoke his DEA Certificate of Registration.'' GX 7, at 3. However, DEA agreed that it would ``not seek to revoke Dr. Nichol's DEA registration . . . unless Dr. Nichol substantially violates this Agreement or unless [he] commits additional acts that constitute grounds under 21 U.S.C. 823(f) and 824(a).'' Id. at 3-4 (emphasis added). In other words, DEA agreed not to seek to revoke Respondent's DEA registration unless he ``substantially violates'' the MOA. Here, I agree with the ALJ's recommendation that I find (and I do find) that Respondent's failure to properly complete two supplier DEA 222 forms alone is insufficient to establish that Respondent ``substantially violate[d]'' the MOA. R.D., at 40 (``I find that the violation of the 2012 MOA, of improperly completing the two supplier 222 Forms, standing along is not a significant violation of the 2012 MOA itself.'') (emphasis in original). Accordingly, I find that Respondent's non-substantial violation of the MOA nominally supports a finding that Respondent's continued registration would be inconsistent with the public interest under Factor Five. Having considered all the factors above, I hold that the Government has established its prima facie case showing that Respondent's registration ``would be inconsistent with the public interest.'' 21 U.S.C. 823(f). Sanction Where, as here, ``the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must `` `present sufficient mitigating evidence to assure the Administrator that [he] can be entrusted with the responsibility carried by such a registration.' ''thnsp;'' Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for its actions and demonstrate that it will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[ ]'' in the public interest determination). An applicant's acceptance of responsibility must be unequivocal. See Alexander, 82 FR at 49728 (collecting cases). Also, an applicant's candor during both an investigation and the hearing itself is an important factor to be considered in determining both whether he has accepted responsibility as well as the appropriate sanction. Michael S. Moore, 76 FR 45867, 45868 (2011); Robert F. Hunt, D.O., 75 FR 49995, 50004 (2010); see also Jeri Hassman, 75 FR 8194, 8236 (2010) (quoting Hoxie, 419 F.3d at 483 (6th Cir. 2005) (``Candor during DEA investigations, regardless of the severity of the violations alleged, is considered by the DEA to be an important factor when assessing whether a physician's registration is consistent with the public interest[.]'')), pet. for rev. denied, 515 Fed. Appx. 667 (9th Cir. 2013). While a registrant must accept responsibility for his misconduct and demonstrate that he will not engage in future misconduct in order to establish that his registration would be consistent with the public interest, DEA has repeatedly held that these are not the only factors that are relevant in determining the appropriate disposition of the matter. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of an applicant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation''); Volkman, 73 FR at 30644; see also Battershell, 76 FR at 44369 (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ``manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant''); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). So too, the Agency can consider the need to deter similar acts, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoption of ``deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions''). After considering (1) Respondent's unlawful pre-signing of prescriptions that his unlicensed staff members then issued to patients without further consulting Respondent and (2) Respondent's failure to properly annotate two supplier DEA 222 forms, the ALJ recommended a sanction of imposing restrictions on Respondent's DEA registration based solely on the sustained recordkeeping violation. R.D., at 41-46. He did not recommend that I impose a sanction of either suspension or revocation. See id. As set forth more fully below, I disagree with the ALJ's recommended sanction. Pre-Signing Prescription Misconduct With respect to Respondent's pre-signing of prescriptions, the ALJ recommended that I do not rely on this misconduct as a basis for any sanction whatsoever. Id. at 42-43 (recommending against relying upon ``Respondent's pre-signing of prescriptions as a basis for revocation or sanction''). The ALJ identified five mitigating actions or factors related to Respondent's unlawful pre-signing of prescriptions to support his Recommendation: (1) Respondent ``obtained high quality prescription pads that make reproduction difficult, and he writes all of his prescriptions by hand'' ``[t]o prevent forgery of his prescriptions;'' (2) ``his prescription pads produce a duplicate copy, which [[Page 47367]] the Respondent keeps in the medical file'' ``[t]o increase the likelihood that he can identify his prescriptions;'' (3) he ``began providing the DEA with copies of his prescriptions, as required by the MOA;'' (4) ``the DEA has renewed his registration multiple times since his medical license was restored;'' and (5) he ``had not been cited for any prescription violations in the past ten years'' and ``the amount of time that has passed since.'' Id. Based on these five factors and the fact that Respondent had accepted responsibility for unlawfully pre- signing prescriptions, the ALJ found that Respondent had taken sufficient ``mitigating actions'' and ``efforts at remediation'' that this unlawful conduct should not be the basis for any sanction whatsoever. Id. at 42-43. Although I agree with the ALJ that Respondent accepted responsibility for unlawfully pre-signing prescriptions, I disagree that there exists sufficient mitigating evidence to warrant no sanction at all for Respondent's pre-signing of prescriptions. For example, Respondent's decision to handwrite his prescriptions on ``high quality prescription pads'' that ``produce a duplicate copy'' is an admirable effort to prevent prescription forgery. However, the ALJ failed to explain how these actions intended to prevent forgery of Respondent's signature on a prescription (the ALJ's first two factors) would remediate or prevent Respondent from again pre-signing prescriptions with his authentic signature in the future. It is manifest that a practitioner, whether he or she pre-signs a ``high quality'' or a ``low-quality'' prescription pad, is still the one signing the prescription in a case like this one involving unlawful pre-signing of prescriptions. Here, there is no allegation that anyone forged Respondent's signature on prescriptions. It is Respondent's pre-signing of his own signature on prescriptions, not forgery, that is the basis for Respondent's unlawful prescription conduct at issue in this case. Thus, I find Respondent's efforts to prevent forgery would not and do not mitigate Respondent's unlawful pre-signing of prescriptions. The ALJ's reliance on Respondent providing DEA with copies of his prescriptions as mitigating evidence (the ALJ's third mitigating factor) is similarly unavailing. As the ALJ concedes, Respondent only provided copies of his prescriptions to DEA because the MOA required him to do so. See R.D., at 42. I find that the fact that Respondent complied with this MOA requirement does not constitute sufficient mitigating evidence regarding his unlawful pre-signing of prescriptions to warrant no sanction for his unlawful conduct. In addition, the ALJ's reliance on DEA's renewals of Respondent's registration in 2010 and 2013 after the ASMB restored Respondent's state license in 2007 as a mitigating factor is misplaced because it overlooks the chronology of DEA's investigation of Respondent. The GS testified that DEA first became aware of Respondent as part of its 2011 investigation of his violations regarding the NKRT-118 study he conducted with Moore Clinical Trials. DEA's 2011 investigation led to the 2011 Show Cause Order against Respondent. The 2011 Order included DEA's allegation that Respondent unlawfully pre-signed prescriptions and that the ASMB suspended him in 2006 for this conduct. Prior to 2011, there is no evidence in the record that DEA was aware of Respondent's misconduct--thereby making any renewals of Respondent's DEA registration prior to 2011 (including the 2010 renewal) irrelevant. Moreover, Respondent and DEA attempted to resolve the 2011 Show Cause Order's allegations by entering into the 2012 MOA. Once Respondent's DEA registration came up for renewal in 2013, DEA renewed it because at that time DEA believed Respondent was complying with the CSA, DEA regulations, and the 2012 MOA. DEA did not learn that Respondent had violated the 2012 MOA until after DEA's July 2014 onsite inspection of Respondent's registered address. As a result of Respondent's violation of the MOA, DEA was entitled to issue a new Show Cause Order against Respondent, which it issued on March 14, 2016, that included the allegations set forth in the earlier 2011 Show Cause Order. Thus, I find that the fact that DEA renewed Respondent's registration in 2010 and 2013 does not constitute evidence mitigating Respondent's unlawful pre-signing of prescriptions. However, I do agree with the ALJ that the final factor he identified constitutes mitigating evidence. Specifically, I find that the amount of time that has passed since Respondent unlawfully pre- signed prescriptions is mitigating evidence because he has not repeated this particular misconduct since 2006. Koch, 79 FR at 18736 (``time is certainly an appropriate factor to be considered'' where `` `during that time [the] Respondent has learned from his past mistakes' '') (quoting Leonardo V. Lopez, M.D., 54 FR 36915, 36915 (1989)). And it is this mitigating evidence, along with the fact that Respondent accepting responsibility, that I consider in imposing a sanction. The Agency has long held that pre-signing prescriptions ``would be inconsistent with the public interest'' under the CSA because such conduct ``create[s] a substantial risk that the drugs would be diverted and abused.'' E.g., Singh, 81 FR at 8248, 8249. And as I noted earlier, Respondent's pre-signing of prescriptions constituted a serious violation of the CSA--not only because it created a substantial risk that the drugs would be diverted and abused but also because Respondent gave the pre-signed prescription forms to office personnel who lacked the authority to lawfully prescribe controlled substances under federal or state law. See 21 CFR 1306.03(a); see also Krishna-Iyer, 71 FR at 52159. Unlike the ALJ, I find that the Agency's interest in deterring this misconduct in the future both on the part of Respondent as well as the community of registrants supports a sanction. The ASMB imposed a six- month suspension of Respondent's state license for unlawfully pre- signing prescriptions. Although there is precedent in the context of pre-signing prescriptions for imposing a sanction to match the ASMB's sanction, cf. Walter S. Gresham, M.D., 57 FR 44213, 44214-15 (1992) (imposing same sanction against respondent who unlawfully pre-signed prescriptions as Georgia imposed), I believe Respondent's acceptance of responsibility for unlawfully pre-signing prescriptions, and the lack of any evidence that Respondent has engaged in this same misconduct since 2006, warrants a lesser sanction than that imposed by the ASMB. Accordingly, I find that suspending Respondent's DEA registration for one month is what is necessary to protect the public interest. As for the issue of specific deterrence, a suspension of Respondent's registration for one month is not a bar on his practice, much less a permanent bar. And regarding general deterrence, those members of the regulated community who contemplate unlawfully pre- signing prescriptions need to know that the Agency takes such misconduct--and the grave risk of diversion that it creates--seriously and that there will be concomitantly serious consequences if they choose to engage in such misconduct. This interest would be compelling even if it was not the case that the nation faces an epidemic of opioid abuse. Recordkeeping Misconduct With respect to the recordkeeping violations, the ALJ stated that this ``violation [of DEA's regulations] is significant because without knowing the [[Page 47368]] quantity of controlled substances shipped back to Fisher, it is impossible to conduct an accurate audit of the Respondent's controlled substances using his records, and it is his records that are the subject of these proceedings.'' R.D., at 43. The ALJ recommended that I find that ``Respondent's recordkeeping violation to be egregious. It was egregious because it prevented the DEA from being able to use the Respondent's own records to conduct an accurate audit of the controlled substances for which the Respondent was accountable while he served as the principal investigator in the controlled drug study.'' Id. at 45. Nevertheless, the ALJ found that Respondent can be entrusted with a DEA registration and recommended that I only place restrictions upon Respondent's registration, rather than revoking or suspending his registration. Id. at 42-43, 45-46. Although the ALJ acknowledged that Respondent ``has not taken any specific remedial steps to address his improper completion of supplier 222 forms,'' the ALJ reasoned that Respondent ``now knows how to properly complete a 222 form when he is a supplier, and he has stated that in the future he will fill out the form correctly.'' Id. at 43 (citing Tr. 257). In short, the ALJ believed that Respondent's ``egregious'' and ``significant'' recordkeeping violations nonetheless warranted only the imposition of restrictions on (and not suspension or revocation of) Respondent's DEA registration because it was the first time Respondent had committed recordkeeping violations. In contrast, the Government argued in its Proposed Findings that Respondent ``has demonstrated, over a period of years, an unwillingness or inability to follow DEA's recordkeeping requirements.'' ALJ Ex. 20, at 21. The Government further argued that Respondent's ``recordkeeping violations that prompted DEA's 2011 Order to Show Cause, which was settled with the 2012 MOA, and his continued violations of these same recordkeeping requirements,'' ``warranted'' ``revocation.'' Id. at 19. In his Recommendation, the ALJ disagreed because he believed that ``the Respondent does not have a history of failing to keep the required records.'' R.D., at 39. The ALJ reached this conclusion because ``Respondent entered into an MOA with the DEA'' ``[t]o resolve the September 2011 [Show Cause Order],'' and ``[n]owhere in the 2011 [Show Cause Order] are recordkeeping violations.'' Id. Elsewhere, the ALJ contested the Government's characterization of Respondent's history of recordkeeping violations: The Government's arguments are puzzling in this regard because the Respondent was not cited for any recordkeeping violations in the 2011 [Show Cause Order], and in its post-hearing brief, the Government does not cite to any recordkeeping violations that occurred prior to the current allegations. . . . Respondent does not have a history of failing to keep the required records. The Government's attempt to paint Respondent's current violations as a continuation of the DEA's concerns that prompted the issuance of the 2011 OSC is disingenuous at best! . . . Here, . . . there is no evidence that the Respondent has a history of improperly completing 222 Forms, either as a purchaser or as a supplier. Id. at 44 (emphasis in original). It is unclear why the ALJ was unaware of Respondent's history of recordkeeping violations, including a history of improperly completing DEA 222 Forms, in light of Moore Clinical Trials. As I noted earlier, Respondent's history of recordkeeping (and other) violations was referenced in the record. In its Proposed Findings filed post-hearing, the Government referenced the GS's testimony that she first became aware of Respondent after receiving an application for a DEA registration from Moore Clinical Trials, and that this application led to a DEA investigation of both Moore Clinical Trials and Respondent in 2011 that found recordkeeping violations. See ALJ Ex. 20, at 4. The Government also referenced the GS's testimony that Moore Clinical Trial's DEA application was denied. Id. The ALJ even acknowledged this denial in his Recommendation. R.D., at 3. Although the Government could have better assisted the ALJ by directing him to a case citation to the Agency's decision, it does not change the fact that Moore Clinical Trials--like all other final agency actions issued by my office--was an Agency decision published in the Federal Register. As such, Moore Clinical Trials compels a finding that Respondent has a history of recordkeeping violations. As already noted, the Agency found in Moore Clinical Trials that Respondent committed both separate registration and recordkeeping violations in connection with the NKRT-118 study Respondent conducted with Moore Clinical Trials that, not coincidentally, correspond to the terms of the MOA. Moore Clinical Trials even documented Respondent's history of recordkeeping violations in connection with DEA 222 forms. For example, the Agency noted the ALJ's findings that Respondent's ``documents'' ``were deficient and that the order forms for Schedule II controlled substances (DEA-222) were lacking'' in connection with the NKRT-118 study. Moore Clinical Trials, 79 FR at 40147 (internal quotations omitted). The then-Administrator also found that Respondent's DEA 222 forms related to the NKRT-118 study did not properly indicate the date the drugs were received and the quantity received. Id. at 40151, 40156. Most significantly, this type of recordkeeping violation involving DEA 222 forms--failure to properly record the date and quantity of controlled substances--is the same type of recordkeeping violation that Respondent committed in this case. Thus, contrary to the ALJ's conclusion, Respondent in fact ``has a history of improperly completing 222 Forms.'' See R.D., at 44. The then-Administrator concluded in Moore Clinical Trials that ``the record clearly establishes that Dr. Nichol violated both the separate registration provision and DEA recordkeeping requirements.'' 79 FR at 40155. The DEA therefore entered into the MOA (which expressly referenced the NKRT-118 study) with Respondent as an intermediary step to get Respondent into compliance and to address Respondent's recordkeeping and separate registration violations related to the NKRT- 118 study described and found by the Agency in Moore Clinical Trials. The ALJ's finding that Respondent's recordkeeping violation in this case is not ``a minor oversight'' but an ``egregious'' and ``significant'' violation, combined with Respondent's history of recordkeeping violations, requires a stronger sanction than what the ALJ recommended. In that vein, I find that the Agency's interest in deterring this misconduct in the future both on the part of Respondent as well as the community of registrants supports imposing a two-part sanction. Although the ALJ's recommended restrictions on Respondent's registration could be a sufficient deterrent for a registrant who lacked a history of recordkeeping violations, that is not this case. Here, the Agency already attempted to address Respondent's prior recordkeeping violations by imposing the restrictions (rather than suspending or revoking his DEA registration) set forth in the MOA. To simply impose more restrictions after Respondent again committed recordkeeping violations would be no sanction at all in this case. See Mark De La Lama, P.A., 76 FR 20011, 20020 (2011) (``granting Respondent's application subject to the restrictions proposed by the ALJ, which do no more than replicate the conditions imposed [[Page 47369]] by the MOA, amounts to no sanction at all. In short, adopting the ALJ's proposed sanction would send the wrong message to both Respondent . . . as well as other applicants/registrants''). For this reason, I find that suspending Respondent's DEA registration for one month (concurrently with the sanction I imposed for Respondent's unlawful pre-signing of prescriptions) is necessary to protect the public interest. In addition, I impose the same restrictions to Respondent's registration as proposed by the ALJ, and I direct that these restrictions--set forth infra--are set to begin at the conclusion of Respondent's one-month suspension. The Agency's interests in both specific and general deterrence support this two-part sanction. As for the Agency's interest in specific deterrence, and as already noted, the one-month suspension of his DEA registration is not a bar on his practice, much less a permanent bar. In addition, the restrictions that I impose in this Decision and Order will hopefully deter Respondent from engaging in future misconduct. As for the Agency's interest in general deterrence, not only does the Agency have an obvious and manifest interest in deterring violations of the CSA and DEA's regulations by members of the regulated community, the Agency also has a manifest interest in ensuring that those members to whom it extends the forbearance of an MOA will comply with the terms of those agreements. Roberto Zayas, M.D., 82 FR 21410, 21430 (2017). I therefore conclude that the suspension of Respondent's DEA registration for one month, in addition to the imposition of the ALJ's recommended restrictions at the conclusion of Respondent's one-month suspension, are necessary to protect the public interest. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. BN4578057, issued to Brian Thomas Nichol, M.D., be, and it hereby is, suspended for one month. At the conclusion of this one-month suspension, I impose the following restrictions on Brian Thomas Nichol's DEA Certificate of Registration No. BN4578057: 1. That he may not participate in any drug studies in which he is required to order, maintain, store, or dispense controlled substances for a period of four years. 2. That he may not order, maintain, store, or dispense any controlled substances at his registered location for a period of four years. 3. That restrictions one and two, above, will not be lifted, even after four years, until the Respondent has completed a course in controlled substance recordkeeping, a course in controlled substance storage, and a course in the administration of controlled substances, and provides the DEA with evidence of completion of these courses. These courses may not be used to meet any continuing medical education requirement. 4. That prior to renewal of the Respondent's DEA registration, he sign a document consenting to inspections by DEA personnel of his medical practice without the need for DEA personnel to obtain an administrative inspection warrant prior to conducting an inspection. By the terms contained in the consent form, the consent shall be valid for four years from the date his current renewal application for a DEA registration is approved. This consent form is to be delivered to the Respondent's local DEA Field Office. 5. That prior to renewal of the Respondent's DEA registration, he sign a document consenting to the conditions set forth in Paragraphs one and two above and acknowledging his understanding that his failure to comply with the terms of those conditions will constitute an independent basis for administrative enforcement proceedings by the DEA. This consent and acknowledgement document shall be delivered to the Respondent's local DEA Field Office. This Order is effective October 19, 2018. Dated: September 5, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018-20383 Filed 9-18-18; 8:45 am] BILLING CODE 4410-09-P
![47352 Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices
Cause at her residence at 1000 Avenue filed any applications for renewal, nor 823(f), 824(a)(4)). For the same reason,
at Port Imperial, Number 706, has she filed a new application for a the Order also proposed the denial of
Weehawken, New Jersey. GX 4 DEA Registration. Accordingly, I find any of Registrant’s ‘‘pending
(Declaration of Service of Order to Show that Registrant’s registrations expired on applications for renewal or modification
Cause) at 1–2. May 31, 2018, and that there is no of such registration, and . . . any
On April 13, 2018, the Government application to act upon. applications for any other DEA
submitted a Request for Final Agency Having reviewed the record, I hold registrations.’’ Id.
Action (RFAA) and the evidentiary that this proceeding is now moot. DEA More specifically, the Show Cause
record to my Office. The Government has long held that ‘‘if a registrant has Order set forth six independent reasons
represented that ‘‘Registrant has not not submitted a timely renewal why the Government alleges that
requested a hearing and has not application prior to the expiration date, Respondent’s registration should be
otherwise corresponded or then the registration expires and there is revoked. Id. at 1–3. The Show Cause
communicated with DEA regarding the nothing to revoke.’’ Donald Brooks Order first charged that Respondent’s
Order served on her, including the filing Reece II, M.D., 77 FR 35054 (2012) ‘‘pre-signing of prescriptions for
of any written statement in lieu of a (quoting Ronald J. Riegel, 63 FR 67132, controlled substances violated [21] 1
hearing.’’ RFAA, at 1–2. 67133 (1998); see also Thomas E. CFR 1306.05(a).’’ Id. at 2. The Order
Based on the Government’s Mitchell, 76 FR 20032, 20033 (2011), states that this charge is based on the
representation that more than 30 days Donald Kenneth Shreves, D.V.M, 83 FR allegation that in 2006, the Arkansas
have now passed since the date of 22518 (2018). Moreover, in the absence State Medical Board found that
service of the Show Cause Order and of an application (whether timely filed Respondent violated Arkansas and
that Registrant has not submitted a or not), there is nothing to act upon. federal laws when (1) he ‘‘pre-signed
request for a hearing or any other reply, Accordingly, because Respondent has controlled substance prescriptions,
I find that Registrant has waived her allowed her registrations to expire and which [his] staff members, who were
right to a hearing or to submit a written has not filed either a renewal or a new not authorized by law to issue such
statement in lieu of a hearing. 21 CFR application, this case is now moot and prescriptions, then issued to patients’’
1301.43(d). I therefore issue this will be dismissed. and (2) he ‘‘[was] not present and [was]
Decision and Final Order based on not consulted by [his] staff when such
relevant evidence contained in the Order
prescriptions were issued.’’ Id. at 1–2.
record submitted by the Government. 21 Pursuant to the authority vested in me The Order further alleged that in 2006,
CFR 1301.43(d) & (e). I make the by 21 U.S.C. 824(a), as well as 28 CFR as a result of these findings, the
following findings of fact. 0.100(b), I order that the Order to Show Arkansas Board suspended
Registrant is the holder of two DEA Cause issued to Sharon C. Worosilo, Respondent’s medical license for six
Registrations pursuant to which she is M.D., be, and it hereby is, dismissed. months. Id. at 2.
authorized to dispense controlled This Order is effective immediately. The Show Cause Order also set forth
substances in schedules II–V as a
practitioner at the registered address of Dated: September 12, 2018. five charges of recordkeeping violations
49 Veronica Avenue, Somerset, New Uttam Dhillon, based on DEA’s July 4, 2014 ‘‘on-site
Jersey (Registration No. BW4026375), Acting Administrator.
inspection of [Respondent’s] registered
and at the registered address of 620 location.’’ Id. First, the Order charged
[FR Doc. 2018–20384 Filed 9–18–18; 8:45 am]
Cranbury Road, Suite #115, East that Respondent ‘‘failed to maintain an
BILLING CODE 4410–09–P
Brunswick, New Jersey (Registration No. initial inventory of all controlled
BW8636219). GX 1 at 1–2. substances in violation of 21 U.S.C.
On April 12, 2018, the Associate Chief DEPARTMENT OF JUSTICE 827(a)(3) & 842(a)(5) and 21 CFR
of the DEA Registration and Program 1304.11(b).’’ Id. Second, the Order
Support Section certified that both Drug Enforcement Administration charged that he ‘‘failed to maintain
registrations were due to expire by their complete and accurate dispensing
[Docket No. 16–22] records in violation of 21 U.S.C.
terms on May 31, 2018. Id. at 1–2. She
further stated that ‘‘[Registrant] has no 827(a)(3) & 842(a)(5) and 21 CFR
Brian Thomas Nichol, M.D., Decision 1304.21(a).’’ Id. at 2–3. Third, the Order
other pending or valid DEA registrations and Order
in New Jersey or in any other state.’’ Id. charged that, during the on-site
at 1–2. Pursuant to 5 U.S.C. 556(e), I On March 14, 2016, the Deputy inspection, Respondent ‘‘could not
take official notice of Registrant’s Assistant Administrator, Office of provide a DEA–222 order form dated
registration record with the Agency. See Diversion Control, Drug Enforcement [January 16, 2014], for an order of
also 21 CFR 1316.59(e).1 Administration, issued an Order to oxycodone tablets, in violation of 21
A review of Agency registration Show Cause to Brian Thomas Nichol, U.S.C. [842](a)(5) and 21 CFR
records shows that Registrant has not M.D. (Respondent), which proposed the 1305.17(a).’’ 2 Id. at 3. Fourth, the Order
revocation of his DEA Certificate of
1 Under the Administrative Procedure Act (APA), 1 Although the Order erroneously referenced Title
Registration No. BN4578057, pursuant
an agency ‘‘may take official notice of facts at any 42 of the Code of Federal Regulations for this
stage in a proceeding—even in the final decision.’’
to which he is authorized to dispense violation, Government counsel corrected the error
U.S. Dept. of Justice, Attorney General’s Manual on controlled substances in schedules II during his Opening Statement at the administrative
the Administrative Procedure Act 80 (1947) (Wm. through V as a practitioner, at the hearing when he made clear that Title 21 was the
W. Gaunt & Sons, Inc., Reprint 1979). In accordance registered address of 5106 McLanahan title that the Government had intended to allege.
amozie on DSK3GDR082PROD with NOTICES1
with the APA and DEA’s regulations, Respondent See Transcript (Tr.) 18. Respondent raised no
is ‘‘entitled on timely request to an opportunity to
Drive, Suite B, North Little Rock, objection based on the erroneous title reference, and
show to the contrary.’’ 5 U.S.C. 556(e); see also 21 Arkansas. Administrative Law Judge I find that this error was merely a scrivener’s error
CFR 1316.59(e). To allow Respondent the Exhibit (ALJ Ex.) 1, at 1. As grounds for and that Respondent had adequate notice of the
opportunity to refute the facts of which I take the proposed action, the Show Cause charged violation.
official notice, Respondent may file a motion for 2 Although the Order erroneously referenced an
reconsideration within 15 calendar days of service
Order alleged that Respondent’s August 28, 2013 DEA 222 form for this charge, the
of this order which shall commence on the date this ‘‘registration would be inconsistent with Government corrected the date of the allegedly
order is mailed. the public interest.’’ Id. (citing 21 U.S.C. missing DEA 222 form to January 16, 2014 in its
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charged that Respondent ‘‘failed to made a timely request for hearing. See The parties submitted briefs of their
properly annotate two DEA–222 order ALJ Ex. 2. The matter was placed on the proposed findings of fact, conclusions of
forms in violation of 21 U.S.C. 842(a)(5) docket of the Office of Administrative law, and argument on October 3, 2016,
and 21 CFR 1305.13(b).’’ Id. Fifth, the Law Judges and assigned to and the ALJ issued his Recommended
Order charged that Respondent ‘‘failed Administrative Law Judge Charles Wm. Decision (R.D.) on December 5, 2016.
to maintain [his] inventory and Dorman (hereinafter, ALJ). On May 19, The ALJ found that the Government
dispensing records at [his] registered 2016, the parties participated in a sustained only two of its charges. First,
location and these records were not telephonic prehearing conference, the ALJ found that the Government had
readily retrievable, in violation of 21 which was not transcribed, and the ALJ sustained its first charge that
U.S.C. 842(a)(5) and 21 CFR 1304.04.’’ issued a Prehearing Ruling and Respondent pre-signed prescriptions in
Id. Related to this last charge, the Order Protective Order (ALJ Ex. 9) violation of 21 CFR 1306.05(a). R.D., at
alleged that Respondent’s ‘‘inventory memorializing 12 accepted stipulations 30. However, the ALJ also found that
and dispensing records were located at of fact (set forth more fully infra) as well Respondent ‘‘has presented sufficient
Moore Clinical Trials,’’ which was not as the terms of a protective order. mitigating evidence’’ concerning this
located at his registered address, and Following other pre-hearing procedures, charge ‘‘to show that he can be
that he ‘‘had not asked for permission to the ALJ conducted an evidentiary entrusted with a DEA registration.’’ Id.
store controlled substance records at a hearing in Little Rock, Arkansas on at 42. As a result, the ALJ did not
central location’’ in violation of 21 CFR August 16–17, 2016, at which both recommend any sanction as a result of
1304.04(a)(1). Id. parties elicited testimony from this violation. See id. at 41–46.
Although the pending Show Cause witnesses and submitted various Second, with respect to the
Order discussed a prior September 27, exhibits.4 Government’s recordkeeping charges,
2011 Show Cause Order that DEA the ALJ only sustained the
issued to revoke Respondent’s DEA 4 On August 23, 2016, Respondent filed a Motion Government’s fourth recordkeeping
to Supplement the Record requesting that the ALJ charge ‘‘that the Respondent failed to
registration, as well as the terms of an accept new exhibits. ALJ Ex. 14. Specifically,
April 27, 2012 Memorandum of Respondent requested leave to supplement the
properly record the date he returned
Agreement (MOA) that was intended to administrative record with the back pages of certain controlled substances to [his supplier]
resolve the charges in that prior Order, DEA 222 forms entered into evidence at the hearing and the amount he returned.’’ Id. at 45.
to rebut a Government witness’s testimony about The ALJ found that, although this
the pending Order did not expressly the instructions contained on those back pages. Id.
charge Respondent with violating the at 1–2. Respondent also attached to his motion the recordkeeping violation also constituted
MOA. See id. at 2. Instead, the affidavit of Matilda Buchanan, who identified and a violation of the MOA, it was not a
Government charged Respondent with
copied these DEA 222 form back pages for purposes sufficiently ‘‘significant violation’’ of
of the motion and who prepared the proposed the MOA to warrant revocation. Id. at 40
violating the MOA in its May 12, 2016 exhibits. See Exhibits 1–2 to ALJ Ex. 14.
Prehearing Statement, and further On August 29, 2016, the Government filed its
(emphasis omitted). The ALJ also
alleged that these violations constituted ‘‘Opposition to Respondent’s Motion to Supplement recommended that I find that this
an independent basis to revoke his
the Record and Government’s Motion for Leave to failure was ‘‘mitigated by the fact that
File Responding Affidavit.’’ ALJ Ex. 16. As a the Government has presented no
registration. See ALJ Ex. 7, at 10–11, 11 threshold matter, the Government contended that
n.4.3 Respondent failed to establish that he had good evidence that Respondent had been
After service of the Show Cause cause for failing to identify the back pages of the previously cited for this type of
Order, Respondent, through his counsel,
DEA 222 forms as exhibits by July 26, 2016, when recordkeeping failure or that this
supplemental prehearing statements were due— recordkeeping failure . . . is in any way
even though Respondent knew that the DEA 222
May 12, 2016 Prehearing Statement and during forms would be introduced and discussed at the related to the Respondent’s day to day
Government counsel’s Opening Statement at the hearing. Id. at 1–2 (citing 21 CFR 1316.57), 5. The treatment of his normal patients.’’ Id. at
administrative hearing. See ALJ Ex. 7, at 8; Tr. 15. Government argued that Respondent’s post-hearing 45. The ALJ concluded that he ‘‘would
In addition, although the Order erroneously motion was an attempt ‘‘to rectify his perceived
oversights made at the hearing’’ for failing to
be exceeding the scope of [his]
referenced Section 821 of Title 21 of the United
States Code for this charge, the Government introduce these back pages as part of his case, responsi[bil]ities were [he] to
corrected the error in its May 12, 2016 Prehearing during cross-examination of the Government’s recommend that the Respondent’s
Statement to Section 842 of Title 21. See ALJ Ex. witness, or in a rebuttal case. Id. at 3. The [registration] be revoked.’’ Id. The ALJ
7, at 8 (‘‘Respondent’s failure to provide the DEA– Government also argued that, in any event,
Respondent had failed to establish a proper added that he ‘‘would reach the same
222 form for this shipment was in violation of 21
U.S.C. 842(a)(5) and 21 CFR 1305.17(a).’’). I find foundation for these supplemental exhibits, and conclusion even if the Government had
that these errors were merely scrivener’s errors and that the Government can no longer cross-examine proven all of its allegations in this weak
Respondent’s affiant, whose affidavit was submitted case.’’ Id. Thus, the ALJ recommended
that Respondent had adequate notice of the charged
in support of these exhibits. Id. at 3–4. Finally, the
violation.
Government requested leave to file its own affidavit that I not revoke Respondent’s
3 ‘‘[P]leadings in administrative proceedings are
in response to Respondent’s affidavit in the event registration and that I approve any
not judged by the standards applied to an
indictment at common law.’’ Moore Clinical Trials,
the ALJ granted Respondent’s motion. Id. at 5. pending application for renewal. Id. The
On the same day, the ALJ issued an order denying ALJ further recommended that I find
L.L.C., 79 FR 40145, 40159 n.34 (quoting Citizens Respondent’s Motion. ALJ Ex. 17. The ALJ found
States Bank of Marshfield v. FDIC, 751 F.2d 209, that Respondent did ‘‘not set forth any reasons in that the testimony of the Government’s
213 (8th Cir. 1984)) (internal citations and his Motion for failing to submit these additional sole witness was not sufficiently
quotations omitted). ‘‘An agency is not required to
give every [Respondent] a complete bill of
exhibits by the July 26, 2016 deadline.’’ Id. at 2. The credible to support any of the
ALJ also found that ‘‘Respondent had the originals Government’s remaining recordkeeping
particulars as to every allegation that [he] will of these exhibits at the hearing and made no
confront.’’ Id. (quoting Boston Carrier, Inc. v. ICC, attempt to offer the back side of the 222 Forms into charges. See, e.g., id. at 4, 15 n.17, 19
746 F.2d 1555, 1560 (D.C. Cir. 1984)) (internal evidence at that time. Therefore, the Respondent n.25, 21 n.28, 34.
citations and quotations omitted). ‘‘Thus, the failure has not established the requisite good cause for Nonetheless, the ALJ found that this
amozie on DSK3GDR082PROD with NOTICES1
of the Government to disclose an allegation in the failing to submit these exhibits in a timely manner.’’
Order to Show Cause is not dispositive, and an
recordkeeping violation ‘‘merits the
Id. Finally, the ALJ found that admitting
issue can be litigated if the Government otherwise ‘‘Respondent’s proposed exhibits would be unfairly imposition of a sanction’’ and found
timely notifies a respondent of its intent to litigate prejudicial to the Government’’ because it ‘‘no that ‘‘Respondent’s recordkeeping
the issue.’’ Id. (quoting George Mathew, M.D., 75 FR longer ha[d] the opportunity to cross-examine violation to be egregious . . . because it
66138, 66146 n.20 (2010)); see also Darrell Risner, Buchanan on the production of the Respondent’s
D.M.D., 61 FR 728, 730 (1996) (‘‘the parameters of additional exhibits, or to introduce additional
prevented the DEA from being able to
the hearing are determined by the prehearing rebuttal testimony or evidence.’’ Id. I agree with the use the Respondent’s own records to
statements’’). ALJ’s ruling. conduct an accurate audit of the
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controlled substances for which the Respondent’s testimony would require Respondent submitted a renewal
Respondent was accountable.’’ Id. at 45. sustaining the Government’s remaining application.5 Government’s Proposed
As a result, the ALJ recommended that recordkeeping charges because the ALJ’s Findings of Fact and Conclusions of
I place the following five restrictions on recommendations regarding those Law (ALJ Ex. 20), at 1 n.2. Because
Respondent’s registration: charges ‘‘hinge[d] on his evaluation of Respondent has submitted a timely
1. That he may not participate in any drug the credibility of the Government’s renewal application, I find that
studies in which he is required to order, investigator and the Respondent.’’ Id. at Respondent’s DEA registration has
maintain, store, or dispense controlled 2 & n.3. Respondent did not file a remained in effect pending the issuance
substances for a period of four years. response to the Government’s of this Decision and Final Order. See 5
2. That he may not order, maintain, store, Exceptions. U.S.C. 558(c); Perry County Food &
or dispense any controlled substances at his Thereafter, the ALJ forwarded the Drug, 80 FR 70084, 70089 n.17 (2015).
registered location for a period of four years. record to me for final agency action. Respondent is an allopathic physician
3. That restrictions one and two, above, Having considered the record in its
will not be lifted, even after four years, until
who is licensed to practice medicine in
entirety, including the Government’s Arkansas. Transcript (Tr.) 137; RX D.
the Respondent has completed a course in
controlled substance recordkeeping, a course Exceptions, I agree with the ALJ’s His specialty is anesthesiology, and his
in controlled substance storage, and a course conclusions that the Government failed current medical practice focuses on pain
in the administration of controlled to prove its first, second, third, and fifth management. Tr. 32, 137–38. During the
substances, and provides the DEA with recordkeeping charges that Respondent hearing, Respondent submitted
evidence of completion of these courses. failed to maintain an initial inventory, evidence establishing that his Arkansas
These courses may not be used to meet any maintain complete and accurate license to practice medicine was active
continuing medical education requirement. dispensing records, provide the DEA
4. That prior to renewal of the
and due to expire on April 30, 2017. RX
222 form dated January 16, 2014, and D, at 1. I have reviewed the official
Respondent’s [DEA registration], he sign a maintain his inventory and dispensing
document consenting to inspections by DEA website of the Arkansas State Medical
personnel of his medical practice without the
records at the registered location. I also Board (ASMB), and it shows that his
need for DEA personnel to obtain an agree with the ALJ that the Government Arkansas medical license is still active
administrative inspection warrant prior to sustained the Show Cause Order’s first and is now due to expire on April 30,
conducting an inspection. By the terms charge regarding Respondent’s pre- 2019. Thus, I take official notice that
contained in the consent form, the consent signing of prescriptions and the Order’s Respondent currently holds an active
shall be valid for four years from the date his fourth recordkeeping charge regarding license to practice medicine from the
current renewal application for a [DEA Respondent’s failure to properly
registration] is approved. This consent form
ASMB.6
annotate two DEA 222 forms.
is to be delivered to the Respondent’s local Furthermore, I agree with the ALJ that The Prior Criminal and Administrative
DEA Field Office. the sustained fourth recordkeeping Proceedings
5. That prior to renewal of the
Respondent’s [DEA registration], he sign a
charge also constituted a violation of the The parties agreed to 12 stipulations,
document consenting to the conditions set MOA. Finally, I also agree that most of which relate to Respondent’s
forth in Paragraphs one and two above and Respondent has accepted responsibility prior criminal and administrative
acknowledging his understanding that his for both of these charges. proceedings.
failure to comply with the terms of those Most importantly, while I agree with
conditions will constitute an independent the ALJ that the sum of Respondent’s Prior State Administrative Proceedings
basis for administrative enforcement misconduct does not warrant revocation The parties stipulated that on June 8,
proceedings by the DEA. This consent and of Respondent’s registration, I disagree
acknowledgement document shall be
2006, the ASMB issued an Emergency
with the ALJ’s recommendation that the Order of Suspension suspending
delivered to the Respondent’s local DEA sanction in this case should be limited
Field Office. Respondent’s Arkansas medical license.
to the ALJ’s recommended restrictions ALJ Ex. 9, at 1. The Order alleged that
Id. at 46. to Respondent’s registration. Respondent violated Ark. Code Ann.
On December 19, 2016, Respondent’s Accordingly, and for reasons I set forth §§ 17–95–409(a)(2)(e), 17–95–
counsel filed a ‘‘Notice of Respondent’s more fully below, I conclude that the 409(A)(2)(g), and 17–95–704(E)(1), (2)
Intent to Comply with Recommended relevant factors support suspension of and federal laws ‘‘regulating the
Rulings, Findings of Fact, Conclusions Respondent’s registration for a period of possession, distribution, or use of
of Law, and Decision’’ in which he one month, in addition to the narcotic or controlled drugs’’ because
stated that Respondent ‘‘intends to imposition of the restrictions that the ‘‘he prescribed or administered
immediately comply with the Court’s ALJ recommended following scheduled drugs intended to manage
Recommended Disposition.’’ ALJ Ex. 23, termination of the suspension. As the
at 1. Respondent also stated that he ultimate fact finder, I make the 5 The parties stipulated that Respondent had
executed a document attached as following findings of fact. previously renewed his DEA registration on
Exhibit A to his Notice entitled December 9, 2010 and on October 21, 2013. ALJ Ex.
‘‘Consent to Conditions and Findings of Fact 9, at 2.
6 Under the Administrative Procedure Act (APA),
Acknowledgment.’’ See id. Respondent is the holder of DEA
an agency ‘‘may take official notice of facts at any
On December 23, 2016, the Certificate of Registration BN4578057, stage in a proceeding—even in the final decision.’’
Government filed Exceptions to the pursuant to which he is authorized to U.S. Dept. of Justice, Attorney General’s Manual on
Recommended Decision. ALJ Ex. 24. In dispense controlled substances in the Administrative Procedure Act 80 (1947) (Wm.
its Exceptions, the Government schedules II through V as a practitioner, W. Gaunt & Sons, Inc., Reprint 1979). In accordance
amozie on DSK3GDR082PROD with NOTICES1
with the APA and DEA’s regulations, Respondent
contended that the ALJ committed error at the registered address of 5106 is ‘‘entitled on timely request to an opportunity to
in finding that Respondent was a more McLanahan Drive, Suite B, North Little show to the contrary.’’ 5 U.S.C. 556(e); see also 21
credible witness than the Government’s Rock, Arkansas. See Attachment to ALJ CFR 1316.59(e). To allow Respondent the
witness, a Diversion Group Supervisor Ex. 7; Respondent’s Exhibit (hereinafter opportunity to refute the facts of which I take
official notice, Respondent may file a motion for
(GS). Id. at 2. The Government further RX) A, at 1. Respondent’s registration reconsideration within 15 calendar days of service
argued that accepting the credibility of was due to expire on October 31, 2016. of this order which shall commence on the date this
the testimony of the GS over See id. On September 12, 2016, order is mailed.
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pain for a patient who had chemical Arkansas medical license for six months felony health care fraud under 18 U.S.C.
dependencies on said controlled drugs and that the ASMB lifted this 1347. ALJ Ex. 9, at 2; see also GXs 3–
and who was diverting said medication suspension on February 2, 2007. See 4. That federal court sentenced
for his addiction.’’ Government Exhibit ALJ Ex. 9, at 2; GX 2, at 3. I also find Respondent to five years of probation
(GX), at 1. This Order also alleged that that, in its final order, the ASMB fined and directed him to pay $15,400.69 in
more specifically, he has pre-signed Respondent over $10,000 and directed restitution and criminal penalties. ALJ
prescriptions leaving the name of the patient, him to complete ‘‘courses in (1) Office Ex. 9, at 2; GX 4, at 2, 4. It is also
substance and the instructions for taking the Management, (2) The Prescribing of undisputed that the court terminated
medication blank and permitting his office Scheduled Medication and [DEA] Laws Respondent’s probation period early on
personnel, who are not licensed physicians, and Regulations . . ., and (3) a course September 20, 2011. R.D., at 6; Tr. 8.
to fill in the prescription. A prescription pad, on boundaries.’’ GX 2, at 4. The parties also stipulated that on
which had all the prescriptions signed by During the hearing, Respondent October 20, 2008, the U.S. Department
Brian Thomas Nichol, M.D. with the rest left
testified that he ‘‘did’’ what ‘‘was of Health and Human Services (HHS)
blank, was found in his office pursuant to a
[federal] search warrant . . . on the 19th of alleged to have happened’’ by the ASMB excluded Respondent from participation
April 2006.’’ in 2006. Tr. 162. That is, he admitted in the Medicare and Medicaid programs
that he improperly pre-signed for five years pursuant to 42 U.S.C.
Id. at 1–2. In the same vein, the Order prescriptions for controlled substances 1320a–7(a). ALJ Ex. 9, at 2; see GX 5.
alleged that Respondent permitted such and that he ‘‘take[s] responsibility’’ for The parties agree that HHS removed this
office personnel to dispense and it. Id. at 274. Respondent testified, exclusion on August 11, 2014. R.D., at
administer scheduled medications to at however, that there were no allegations 7; Tr. 9.
least three patients, and fraudulently of ‘‘diversions [sic] resulting from that’’
billed one of these patients for $22,600. Prior DEA Administrative Proceedings
conduct. Id. at 162. Respondent later
Id. at 2–3. The Order further alleged that testified more broadly that he agreed to The Group Supervisor testified that
Respondent ‘‘performed medical the conditions of the MOA ‘‘even DEA ‘‘first bec[a]me aware of Dr.
procedures and engaged in the practice though there was [sic] never any Nichol’’ in 2011 after DEA received an
of medicine in the State of Arkansas allegations of diversion.’’ Id. at 174. application for a registration as a
. . . while not having a valid Arkansas However, the ASMB’s earlier Emergency researcher from Moore Clinical Trials.
license’’ to do so. Id. at 2. Based on Order alleged that Respondent Tr. 28. ‘‘[I]n the review of that
these allegations, the ASMB found that ‘‘prescribed or administered scheduled application, we became aware that Dr.
Respondent’s acts ‘‘endanger[ed] the drugs intended to manage pain for a Nichol was associated with Moore
public health, safety and welfare’’ and patient who had chemical dependencies Clinical Trials . . . we saw that there
suspended his state license on an on said controlled drugs and who was was a current research study going on[,]
emergency basis pending a hearing. Id. diverting said medication for his and we noticed several violations of
at 3. addiction.’’ GX 1, at 1 (emphasis added). [DEA regulations] and the Controlled
The parties further stipulated that on More specifically, the ASMB also Substances Act.’’ Id. More specifically,
August 17, 2006, the ASMB held an alleged that Respondent ‘‘prescribed or she testified that DEA conducted an
administrative hearing based on the administered controlled substances investigation of both Moore Clinical
allegations set forth in the ASMB’s when he knew or should have known Trials and Respondent and ‘‘looked at
Emergency Order, and issued its Final that his patient was utilizing the drugs the records and found that the receiving
Order on the same day. See ALJ Ex. 9, for non-therapeutic purposes and was records and dispensing records weren’t
at 1; GX 2. The parties also stipulated chemically dependent on said drugs.’’ up to the regulations.’’ Id. at 28–29. As
that ‘‘[t]he ASMB’s final order did not Id. at 3. Thus, while I accept a result, DEA brought separate
include all of the allegations made in Respondent’s testimony that he administrative actions against each of
the ‘Emergency Order.’ ’’ ALJ Ex. 9, at 2. admitted to improperly pre-signing them in 2011—one against Moore
However, the ASMB’s Final Order does prescriptions, I do not accept Clinical Trials to deny its application
state findings that Respondent Respondent’s statement that there were for a DEA registration as a researcher,
‘‘admitted in testimony that he has never any allegations of diversion and the other against Respondent to
violated the laws of the United States against him. revoke his DEA registration as a
and the State of Arkansas regulating the Based on Respondent’s representation practitioner. See id. at 28–29; GX 6.
prescribing of scheduled medication, in his testimony, the ALJ found that With respect to Moore Clinical Trials,
more specifically, he has pre-signed Respondent has written every the GS testified that ‘‘subsequently the
prescriptions, and not written on the prescription himself since the application for Moore Clinical Trials
prescription the name of the patient, the expiration of the state’s suspension. was denied.’’ Id. at 29. In fact, the
substance prescribed, and instructions R.D., at 10 (citing Tr. 166). The Agency issued and published its final
for taking the medication.’’ GX 2, at 1. Government introduced no evidence decision and order denying Moore
The ASMB also found that Respondent contradicting Respondent’s testimony. Clinical Trials’ application pursuant to
admitted that he ‘‘permitted his office Thus, I find that there is no evidence an August 8, 2011 Show Cause Order.
personnel, . . . who are not licensed as that Respondent resumed pre-signing Moore Clinical Trials, L.L.C., 79 FR
physicians, nor authorized to prescribe prescriptions after his suspension by the 40145, 40145 (2014). In that decision,
medication, to fill in the blanks on the ASMB. the then-Administrator found that
prescription pad and distribute them to Moore Clinical Trials ‘‘entered into a
patients, even without Dr. Nichol being Prior Federal Criminal Proceedings contract with Dr. Brian Nichol, an
amozie on DSK3GDR082PROD with NOTICES1
present.’’ Id. The parties stipulated that on January interventional pain management
The parties stipulated that the ASMB 8, 2008, 11 months after the specialist, to perform clinical research
found that this conduct violated reinstatement of his state medical for it pursuant to contracts it might
Arkansas and federal laws. ALJ Ex. 9, at license, Respondent pled guilty in the obtain from CROs [contract research
1–2; see GX 2, at 3. As a result of these United States District Court for the organizations].’’ Id. at 40148. The then-
findings, it is also undisputed that the District of Arkansas to a one-count Administrator noted the ALJ’s finding
ASMB suspended Respondent’s criminal information charging him with that ‘‘ ‘the documents kept by Dr.
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Nichol,’ who was supervising . . . establishes that Dr. Nichol violated both 2012.11 ALJ Ex. 9, at 2; GX 7. The GS
clinical trials on behalf of [Moore the separate registration provision and testified that the MOA was ‘‘an
Clinical Trials], ‘were deficient’ and that DEA recordkeeping requirements.’’ Id. intermediary step trying to get
the order forms for Schedule II at 40155.8 [Respondent] into compliance.’’ Tr.
controlled substances (DEA–222) ‘were With respect to the instant charges 29.12 Both Respondent and his
lacking.’ ’’ Id. at 40147 (quoting ALJ’s against Respondent, the parties investigator/assistant, Matilda
Recommended Decision). ‘‘The ALJ also stipulated that DEA issued a Show Buchanan, testified that the MOA was
found that ‘Dr. Nichol transported Cause Order against Respondent on the product of back-and-forth
controlled substances to [Moore Clinical negotiations by the parties. Id. at 173–
September 27, 2011 proposing the
Trials’] location,’ where he was not 74 (Respondent testifying that ‘‘there
revocation of his DEA registration on
registered to dispense them.’’ Id. The was some negotiation back and forth
the ground that it is ‘‘based, inter alia,
then-Administrator also noted that ‘‘the before we settled on the final
on the findings of the ASMB and
ALJ found that the evidence is clear that agreement’’ and ‘‘I think it was the third
Nichol’s records did not comply with respondent’s exclusion from Medicare or fourth [version] that we were both
the Controlled Substances Act or DEA and Medicaid.’’ ALJ Ex. 9, at 2; see also able to agree to terms on’’), 425–26 (Ms.
regulations’’ and ‘‘ ‘Nichol[] fail[ed] to GX 6. More specifically, the 2011 Show Buchanan testifying that ‘‘drafts were
meet his responsibilities as a Cause Order proposed to revoke his sent back and forth’’ and that ‘‘we went
registrant.’ ’’ Id. registration as ‘‘inconsistent with the over line by line both what the MOA
The then-Administrator made public interest’’ based on three said and then what does that mean by
additional specific fact findings in allegations. GX 6, at 1 (citing 21 U.S.C. what it said’’).
Moore Clinical Trials regarding 823(f), 824(a)(4)). First, the 2011 Order The MOA imposed the following
Respondent. Specifically, she found that alleged that Respondent’s pre-signing of conditions, in pertinent part, on
on March 30, 2011, Moore Clinical controlled substances prescriptions, as Respondent:
Trials and Respondent ‘‘entered into a found by the ASMB, warranted
1. Respondent must ‘‘abide by all Federal,
Clinical Trial Agreement (CTA) with revocation. Id. (citing 21 U.S.C. State and local statutes and regulations
Quintiles, to participate in the NKTR– 824(a)(3), (4)). Second, the 2011 Order relating to controlled substances.’’
118 7 long-term safety study.’’ Id. at alleged that Respondent’s registration 2. Respondent must ‘‘make and keep
40149. She further found that, during must be revoked because of his records of all controlled substances that he
the investigation of Moore Clinical exclusion for five years from
Trials, the DI in the case ‘‘contacted Mr. participation in a Medicare and 11 The Special Agent in Charge for DEA’s New
Medicaid program under 42 U.S.C. Orleans Division approved and signed the MOA on
Jim Phillips, Dr. Nichol’s attorney,’’ who April 17, 2012, Respondent and his counsel signed
‘‘acknowledged that Nichol was 1320a-7(a). Id. at 2 (citing 21 U.S.C. it on April 20, 2012, and DEA’s counsel signed it
involved in the study and that he was 824(a)(5)). Lastly, the 2011 Order on April 27, 2012. GX 7, at 4.
transporting the controlled substances alleged that, ‘‘[o]n or about September 12 The ALJ questioned this testimony based on his
17, 2010, [Respondent] contracted with finding that that the MOA ‘‘does not address any
to [Moore Clinical Trials] and of the alleged violations contained in the 2011
dispensing them.’’ Id. at 40150. ‘‘The DI a controlled substance researcher [Show Cause Order].’’ R.D., at 10. The ALJ’s
also requested of Mr. Phillips that Dr. [Moore Clinical Trials] to administer assessment is confusing for at least two reasons.
Nichol provide his records, including controlled substances 9 to research First, the parties stipulated that the MOA does, in
fact, resolve the 2011 Order’s allegations against
the dispensing records and the schedule subjects. The owner/operator of this Respondent, ALJ Ex. 9, at 2, and the ALJ accepted
II order forms (DEA Form 222).’’ Id. The research clinic has no experience the parties’ stipulation. R.D. at 7. That the parties
then-Administrator found that the handling controlled substances, and you repeated the allegations from the 2011 Show Cause
‘‘evidence also shows that in response [Respondent] and the owner/operator Order in the MOA itself, see GX 7, at 1–2, makes
the fact that the parties intended the MOA to
to the GS’s request (through Dr. Nichol’s [of Moore Clinical Trials] gave address and to resolve the 2011 Order’s allegations
attorney) for Dr. Nichol’s dispensing conflicting information about the irrefutable. Apart from the parties’ agreement, the
records, Nichol provided the GS with operation of this research clinic.’’ Id. third allegation of the 2011 Order (though
the records.’’ Id. at 40156. The then- unartfully worded) clearly references Respondent’s
The parties have further stipulated role in the operations of Moore Clinical Trials. As
Administrator accepted the GS’s that Respondent entered into an MOA already noted, Moore Clinical Trials received its
testimony that the original DEA 222 with DEA to resolve the allegations in own Show Cause Order in August 2011, less than
forms related to the NKTR–118 study two months before the September 2011 Show Cause
the 2011 Show Cause Order,10 and that Order that was issued to Respondent.
‘‘were kept at Dr. Nichol’s registered the MOA became effective on April 27, From there, Respondent and Moore Clinical
location’’ and that ‘‘the forms did not Trials took two different procedural paths.
indicate the date the drugs were 8 The then-Administrator also found that ‘‘it is
Respondent entered into an MOA and retained his
received and the quantity received.’’ Id. DEA registration subject to the MOA’s conditions;
undisputed that the dispensing record for each Moore Clinical Trials went to hearing and the
at 40151 (internal quotations and study—which Dr. Nichol provided—was not Agency issued a final decision and order denying
citations omitted), 40156 (adopting GS’s created until August 27, 2012, well after all of the its application for a DEA registration. As already
testimony that ‘‘she examined the dispensings were made. The CSA requires, noted, Moore Clinical Trials discussed
however, that a dispensing record be ‘maintain[ed], Respondent’s recordkeeping violations (which
Schedule II order forms and noted that on a current basis.’ 21 U.S.C. 827(a)(3).’’ Id. at precede the ones in this case) at length. When
they had not been completed by 40156 (internal citations omitted). comparing that discussion to the MOA, it is obvious
indicating the date the drugs were 9 The Memorandum of Agreement resolving the
that the MOA addresses the allegations against
received and the quantity received’’). 2011 Order, discussed more fully infra, specified Respondent and reflects the ‘‘intermediary step’’
that the alleged controlled substance referenced in that the GS referenced in her testimony. See 79 FR
Ultimately, the then-Administrator that Order’s third allegation was NKRT–118. See at 40151 n.10 (‘‘Notwithstanding these allegations,
concluded that ‘‘the record clearly
amozie on DSK3GDR082PROD with NOTICES1
GX 7, at 1. the Agency allowed Dr. Nichol to retain his
10 This stipulation is also consistent with how the registration subject to various terms and
7 ‘‘NKTR–118’’ is the drug Naloxol 6a- then-Administrator characterized the MOA. Moore conditions’’ set forth in the MOA).
methoxyhepta (ethylene glycol) ether. Id. at 40148. Clinical Trials, 79 FR at 40151 n.10 Second, in any event, even if the MOA had failed
‘‘The [full] name of the study was: ‘An Open-Label (‘‘Notwithstanding these allegations [in the 2011 to address the allegations in the 2011 Show Cause
52-week Study to Assess the Long-Term Safety of Show Cause Order], the Agency allowed Dr. Nichol Order, as the ALJ suggested, he failed to explain
NKRT–118 in Opioid-Induced Constipation (OIC) in to retain his registration subject to various terms why that is relevant. What is relevant is the fact that
patients with Non-Cancer-Related Pain.’ ’’ Id. at and conditions’’ set forth in a Memorandum of Respondent and the Government agreed that the
40148 n.4. Agreement (MOA)); see also GX 7. MOA resolved the 2011 Show Cause Order.
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prescribes, dispenses and administers at his SITE’’ for the study. RX N, at 1. And expected to start enrolling patients in
DEA registered location. These . . . Quintiles was an independent the study . . . to start in Januaryish
dispensing records shall include all the contractor acting on behalf of the [sic].’’ Tr. 401. Respondent testified that
information . . . set forth and required by 21
‘‘Sponsor’’ of the study (Purdue Pharma, enrollment is when they have ‘‘met all
CFR 1306.05(a) and 1304.21 where
applicable. These . . . dispensing records L.P.) and would ‘‘arrange and manage’’ the qualifications for it and are actually
shall be available for inspection as set forth the clinical trial. Id. starting to see me as a patient. That’s
in paragraph 4 of this Agreement.’’ This study was designed to be a enrolled.’’ Id. There is no evidence in
3. Respondent must ‘‘make and keep a double blind study in which the record contradicting this testimony.
legible log of all Schedule II–V controlled Respondent would dispense oxycodone, Thus, I find that Respondent began
substances that he prescribes for his which is a schedule II controlled enrolling patients for the Quintiles
patients.’’ substance, to study patients. Tr. 35, 182 study in January 2013.
4. Respondent must ‘‘retain the records of (the study was a ‘‘double blind, double
the prescribing, administering and dummy placebo controlled study’’). Mr. Phillips’ response to the second
dispensing records, as described in paragraph
However, because this was a double question is consistent with the GS’s and
2, at his DEA registered location and agrees Respondent’s testimony regarding the
to allow DEA personnel access to his blind study, Respondent did not know
what other type of medication a study study. The GS testified that it was her
controlled substance records for [these] ‘‘understanding that Dr. Nichol does the
records as described in paragraph 2 for patient received. Id. at 35, 184.
purposes of verifying his compliance with Respondent first placed an order for physical evaluations and actual
this Agreement and with all Federal, state controlled substances related to the dispensing of the controlled substances
and local statutes and regulations relating to study on December 3, 2012, and on from his registered location.’’ Tr. 36.
controlled substances.’’ December 31, 2012, he notified the GS ‘‘[T]he other types of monitoring and
5. ‘‘During the duration of the Agreement, (by letter from his attorney) that he was testing is done at Moore Clinical Trials.’’
Dr. Nichol shall notify DEA in writing if he Id. The GS further testified that it was
will prescribe, dispense, or administer
participating in the study. Id. at 93–94,
120–21; see RX R, at 1. In the letter, her understanding that the study
controlled substances at any other location ‘‘concluded in June of 2014.’’ Id.
other than his DEA registered address or Respondent’s attorney, Mr. Phillips,
added that ‘‘[t]his trial is to begin in Respondent testified that he first saw
Springhill Surgery Center. . . .’’
6. Respondent ‘‘shall not order or receive January 2013. . . . [T]his notice is our study patients in February 2013. Id. at
any controlled substances except for compliance with paragraph 6 of the 210–211. Respondent’s dispensing log is
controlled substances that he orders and MOA. Dr. Nichol will only administer also consistent with this testimony,
receives at his DEA registered location. . . . the study drugs at his DEA approved showing that the first time he dispensed
As the physician, who is contracted to address.’’ RX R, at 1. a controlled substance (here,
administer the FDA approved study drug Although the complete email that the oxycodone) to a patient as part of the
NKTR–118, [Respondent] will administer GS sent in response to Mr. Phillips’ study was February 18, 2013. RX U, at
that drug at either his DEA registered 1.13 Thus, I find that Respondent first
location or at an approved site for the current
December 31, 2012 letter is not in the
record, the January 17, 2013 letter that dispensed controlled substances to
drug study. . . . [Respondent] agrees that for
the duration of this agreement if he is asked Mr. Phillips sent to the GS in response study patients on February 18, 2013.
to participate in additional drug studies to that email was admitted into Accord R.D., at 13.
involving controlled substances, he will evidence. See id. at 3. Specifically, the During the term of the CTA, Quintiles
notify DEA in advance of commencing the January 17, 2013 letter states that it is and the Sponsor reserved the ‘‘right to
study.’’ in response to two questions posed in a audit’’ Moore Clinical Trials’ ‘‘facilities,
7. Respondent ‘‘understands and agrees January 11, 2013 email that the GS had records and documentation.’’ RX N, at 6.
that any violations of the Agreement may sent to Mr. Phillips in response to his
result in the initiation of proceedings to Respondent testified that such audits
earlier letter. Id. The response to the included Quintiles inspectors visiting
revoke or immediately suspend and revoke
his DEA Certificate of Registration. . . . DEA
first question apparently posed by the Respondent’s office as well to review
and [Respondent] agree this is a final agency GS regarded when the study would his study documentation. Tr. 189–90.
action on all matters in dispute. DEA will not begin and how long it would be. See id. Respondent testified that Quintiles’
seek to revoke [Respondent’s] DEA Mr. Phillips stated that ‘‘the study we inspectors or monitors ‘‘would do a
registration or deny any renewal applications referred to should begin January 2013. complete inventory of all the narcotics.’’
unless [Respondent] substantially violates The study length is approximately 22 Id. at 190. Respondent also said that the
this Agreement or unless [Respondent] weeks for each subject enrolled. . . . monitors required him ‘‘to get the
commits additional acts that constitute Enrollment is ongoing until the clinical
grounds under 21 U.S.C. 823(f) and 824(a).’’ inventory down to the serial number of
trial end points are met. In all each individual kit, down to the serial
GX 7, at 2–4. The MOA also stated that likelihood, the study will be about a number of each individual bottle. Any
these conditions would remain in effect year in length.’’ See id. The second returns that the patient had, they would
for three years. Id. at 4. response was to the GS’s ‘‘other count each individual one. They would
question’’ asking ‘‘What is the location account for those quantities.’’ Id.
The Quintiles Clinical Trial and Study and your understanding of the Finally, Respondent stated that he
On July 11, 2012, Respondent, Moore ‘approved’ DEA address?’’ Id. Mr. would ask the monitor ‘‘when she was
Clinical Trials, and Quintiles, Inc. Phillips stated that the address to which wrapping things up is is [sic] my pill
entered into a ‘‘Clinical Trial Agreement he was referring was Respondent’s count fine. . . . And every time I had
Effective July 6, 2012’’ (hereinafter, registered location of ‘‘5106 McLanahan,
CTA) to conduct a study related to Suite B, North Little Rock, AR 72116,’’
amozie on DSK3GDR082PROD with NOTICES1
13 Respondent testified that he ‘‘had seven or
opiate induced constipation. RX N, at 1, and that ‘‘[a]ll study drugs will be eight’’ study patients who ‘‘actually enrolled in the
11; Tr. 35. The CTA prescribed a role for administered at this DEA-approved study and only one patient, I think, or two patients
each party. Respondent was the address.’’ Id. that completed this study all the way to the end.’’
‘‘principal investigator’’ of the study. Mr. Phillips’ response to the first Tr. 358, 398 (‘‘I had two [patients who] completed
it’’). Respondent defined ‘‘completed’’ as ‘‘when
Moore Clinical Trials, located at 3508 question is consistent with they’ve gone through the full length of the study to
JFK Blvd., Suite #1, North Little Rock, Respondent’s testimony at the hearing. . . . where they actually completed the study at the
Arkansas, was the ‘‘INVESTIGATIVE Specifically, he testified that ‘‘we end.’’ Id. at 401.
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full count of the narcotics. So there The July 9, 2014 On-Site Inspection asked for receipts. And because these
wasn’t any diversion.’’ Id. at 191. are Schedule II controlled substances,
Inspection of Respondent’s Registered
Most important, Respondent testified we asked for DEA order form 222s.’’ Id.
Location
that Quintiles had provided records that at 37–38; see also id. at 102 (‘‘We asked
The parties stipulated that on ‘‘July 9, for dispensing records, inventories. . . .
allowed for a calculation of every 2014, while the MOA was still in effect, we ask for any kind of documents
controlled substance pill received and DEA conducted an on-site inspection of showing receipts or dispensations.’’).
that Quintiles accounted for every pill at Respondent’s registered location.’’ ALJ She also testified that ‘‘[h]e did not have
the end of the study. Id. at 187, 301. To Ex. 9, at 3. Three DIs participated in the an inventory on hand.’’ Id. at 52.
support this claim, Respondent inspection. See id.; ALJ Ex. 7, at 4 & n.1; Respondent testified that he did not
introduced a series of documents ALJ Ex. 11, at 1 n.1. The DI who had ‘‘recall’’ whether the GS had asked for
prepared by others which the ALJ lead responsibility for conducting the his DEA 222 forms or dispensing logs
admitted into the record. For example, inspection was unable to testify at the and stated that he ‘‘d[id]n’t think’’ she
Respondent introduced copies of a hearing for medical reasons. ALJ Ex. 11, had asked for his inventory. Tr. 213.
series of reports or reviews prepared by at 1 n.1. Although a third DI Instead, he stated that the DIs ‘‘wanted
Quintiles (and obtained from Moore accompanied the GS and the lead DI my paperwork for the study.’’ Id. at
Clinical Trials) of Quintiles monitors’ who conducted the on-site inspection, 212–13, 214 (‘‘When they found out
site visits to Respondent’s office to that third DI also did not testify. Thus, there weren’t any drugs there to collect,
ensure he was following the drug study only the GS testified on behalf of the they wanted the paperwork’’). In
protocol. See RX Y; Tr. 262–63, 378–79, Government at the hearing. Id. response, Respondent stated that he
The GS testified that the DIs ‘‘went to made his DEA 222 forms ‘‘available for
454–56. Respondent also introduced
Dr. Nichol’s registered location . . . to Agent Barnhill to review,’’ and the GS
accountability logs kept at Moore
ensure that he was in compliance with acknowledged that the DIs reviewed at
Clinical Trials for the drug study. RX Z; the MOA.’’ Tr. 31. Under the MOA,
Tr. 456–57. Finally, Respondent least some of these forms. Id. at 39, 214;
Respondent had agreed ‘‘to allow DEA see also RX S. Respondent also stated
introduced copies of work records that personnel access to his controlled that he ‘‘kept a green binder with all of
Quintiles had created during site substance records for the prescribing, the computation charts’’ (that
inspections and while conducting their administering, and dispensing records Respondent stated included an initial
inventories. RX AA; Tr. 457–58. . . . for purposes of verifying his inventory) and ‘‘provided’’ them and his
However, none of these documents, compliance with [the MOA] and with dispensing log ‘‘to the agents when they
separately or taken together, were all Federal, state and local statutes and came to see me in my office on July
sufficient to make an accurate pill regulations relating to controlled 9th.’’ Tr. 224, 226, 236–37; RX U; RX
count. Moreover, Respondent failed to substances.’’ GX 7, at 2. Although the V.14
introduce any other documentary inspection was unannounced, The GS acknowledged that
evidence or testimony from a Quintiles Respondent allowed the DIs ‘‘access Respondent ‘‘did give us some
employee corroborating Respondent’s onto the premises to review records . . . documents’’ and that the DIs reviewed
testimony that Quintiles’ records [a]nd he signed an actual Notice of these documents ‘‘in his office.’’ Tr. 101,
allowed for an accurate ‘‘pill count’’ of Inspection.’’ Tr. 99; see also id. at 31– 102 (‘‘he showed us some documents’’).
the pills Respondent had received. 32; July 9, 2014 Notice of Inspection The GS recalled that Respondent
Accord R.D., at 18 nn. 22–23. At the (GX 8). The inspection period was from ‘‘produced five DEA 222 order forms for
same time, the Government offered no December 19, 2012 through July 9, 2014. purchase. And he gave us two DEA
Tr. 38, 62. The inspection took one order forms for returns back to the
documentary evidence or testimony
hour, and the GS testified that supplier.’’ Id. at 39; see GX 9 (DEA 222
from a Quintiles employee to rebut
Respondent’s ‘‘assistant Xeroxed for us forms submitted by the Government).
Respondent’s testimony. See id. the documents we needed.’’ Id. at 102. During cross-examination, Respondent’s
Indeed, it is equally possible for Initially, the DIs asked Respondent attorney asked the GS:
Quintiles to have done a ‘‘complete where the ‘‘study drugs’’ were ‘‘because Q Did [Respondent] show you documents
inventory’’ and found that Respondent’s at that point in time we didn’t know the other than the 222 forms? He did, didn’t he?
pill count was ‘‘fine,’’ and at the same study had been completed.’’ Tr. 99. A I don’t recall that.
time for Respondent to have nonetheless Once it became clear that Respondent Q You don’t recall that?
failed to maintain complete and no longer had any study drugs and ‘‘that A No.
accurate dispensing records pursuant to there were no drug destructions during Tr. 102–03. Whatever other
the CSA and as alleged in the Show that time period or theft or losses’’ (id. documents Respondent may have
Cause Order’s second recordkeeping at 39–40), the GS testified that ‘‘we provided to the GS, she did not
charge. Respondent’s recordkeeping is asked for any incoming documents [sic] recognize them as an initial inventory or
what is at issue in this case, not receipts. We asked for any inventories. as dispensing records. See id. at 39 (GS’s
We also asked for any outgoing records testimony that Respondent ‘‘was unable
Quintiles’ recordkeeping. Without a
which could include dispensing to produce the initial inventory that we
showing by a preponderance of the
records, returns, theft and loss reports, requested. And he was unable to
evidence that the recordkeeping drug destruction. Anything showing the
requirements of Quintiles and the CSA produce dispensing records’’).
movement of controlled substances in or The GS testified that she did not
are coextensive, I find that Respondent’s out of that registered location.’’ Id. at recall giving Respondent a ‘‘written list
amozie on DSK3GDR082PROD with NOTICES1
testimony regarding the Quintiles audits 36–37. The GS stated that ‘‘this is
and documents in the record rests on typical of any inspection.’’ Id. at 36. 14 The ALJ recommended that I find that
too thin a reed for me to accord it When asked if she could ‘‘be more ‘‘Respondent provided the DEA investigators his
meaningful evidentiary weight specific about what inventories and 222 Forms, his dispensing logs, and an initial
regarding whether Respondent’s inventory.’’ R.D., at 15 (citing Tr. 214). In the
dispensing records you specifically testimony cited by the ALJ, however, Respondent
recordkeeping complied with the CSA asked for,’’ she responded that ‘‘[w]e only testified that he made the DEA 222 forms
and DEA’s regulations. asked for an initial inventory . . . We ‘‘available for [the GS] to review.’’ See Tr. 214.
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of items’’ that the DIs had requested. Tr. years with the DEA and had been a findings and stated that, ‘‘[a]ssuming the
100. She also testified that she did not Group Supervisor for over six of those DEA investigator’s testimony is
provide Respondent (1) a list of items years, so she should know how DIs accepted over Respondent’s testimony,
that the DIs did in fact receive, (2) a list typically conduct audits. See id. at 25, then it would be established that the
of items to which she had testified were 59; ALJ Ex. 24, at 4–5. Likewise, initial inventory, dispensing records,
missing, or (3) a list of items that the DIs Respondent may also be correct in his and missing DEA–222 form were not
photocopied on the date of inspection. recollection that, for his particular provided to the investigators at the time
Id. at 100–01, 112 (‘‘Records can be inspection, the DIs asked more generally of DEA’s on-site visit and therefore
fabricated. So, no, we don’t leave a list. for ‘‘paperwork’’ related to the Quintiles DEA’s allegations in the Order to Show
The records must be onsite when we study. E.g., Tr. 212–13. Moreover, the Cause would be sustained.’’ ALJ Ex. 24,
arrive.’’). Respondent testified that, had same could be true for whether at 2 n.3. However, and for the reasons
the DIs advised him that he was missing Respondent provided an initial already noted, even assuming arguendo
something, he would have provided it to inventory and dispensing log. Thus, the that the GS’s testimony was credible, it
them. Id. at 236. fact that the GS herself did not see or would be insufficient to establish by a
The GS’s use of the phrase ‘‘we’’ or recognize these documents does not preponderance of the evidence that
‘‘us’’ is significant and occurs frequently preclude the possibility that Respondent Respondent failed to provide the DIs
throughout her testimony regarding the provided them to one of the other DIs with an initial inventory or dispensing
inspection. In these instances, she was at the inspection. logs during their July 9, 2014
either testifying to what she Rather than reflecting a conflict, this inspection.
remembered hearing someone else testimony highlights a gap in the
(presumably, the lead DI) ask Inspection of Moore Clinical Trials
Government’s evidence. The GS’s
Respondent, e.g., Tr. 103 (GS testifying testimony that DIs conducting Later the same say, after conducting
that she was ‘‘present when [the lead DI] inspections typically ask for DEA 222 their inspection of Respondent’s
asked [Respondent] for documents’’), or forms, inventories, and dispensing registered location, the DIs went to
she was testifying to what she would records is insufficient to establish by a Moore Clinical Trials. See Tr. 56.
typically request from a registrant preponderance of the evidence that the Although the GS and Respondent
during an inspection (or to both). See id. lead DI asked for these documents in provide conflicting testimony regarding
(GS’s testimony that she did not ‘‘take this particular case. The lead DI who the why Respondent directed the DIs to
notes of what was asked for’’ but noted GS testified had made the requests for Moore Clinical Trials,19 the Government
that ‘‘[i]t’s the same things we ask for this paperwork (and who was most
every time’’).15 In any event, the GS did likely to have received the response)
19 The GS testified that Respondent directed the
not testify that she herself made these DIs to Moore Clinical Trials because that was where
during the inspection did not testify at they could find records related to the study. Tr.
requests of Respondent, and she did not the hearing. Moreover, the Government 478–79. This testimony is consistent with
‘‘take notes of what was asked for.’’ Id. did not offer as a witness the third DI Respondent’s testimony that the DIs ‘‘wanted my
Thus, while the record is clear that the present during the inspection to
paperwork for the study.’’ Id. at 213. After this
GS did not recall reviewing documents point, however, the clarity ends. Respondent
corroborate the GS’s testimony.17 For testified that the question of patient names and
that she recognized as an initial these reasons, the record created by the addresses came up and that he therefore referred
inventory or as dispensing logs at Government is insufficient to establish the DIs to Moore Clinical Trials for paperwork more
Respondent’s office during the specifically related to patient names and addresses
by a preponderance of the evidence that (the Quintiles Study precluded Respondent from
inspection (id. at 39), the record is
Respondent failed to provide the DIs knowing the patients’ names). See id. at 279, 374.
unclear whether the other two DIs On rebuttal, the GS testified that the DIs went to
with what Respondent characterized as
reviewed and recognized what Moore Clinical Trials because Respondent advised
his initial inventory 18 and dispensing
Respondent submitted were his initial that he did not have in his office the records related
logs during the July 9, 2014 inspection. to the study that they cared about—i.e., an initial
inventory and dispensing logs.16
For this reason, I disagree with the And for the same reasons, I need not inventory and dispensing records—at his registered
reach the credibility issue raised by the location because they were at Moore Clinical Trials.
ALJ’s statement that ‘‘[t]here is a conflict Id. at 56 (‘‘Upon learning that the dispensing
in testimony concerning what the DEA ALJ and the Government in its records were at Moore Clinical Trials . . . [and
investigators specifically asked for’’ Exceptions of whether the GS’s a]fter our onsite inspection completed at Dr.
during the inspection because both the testimony was more credible than Nichols, we went straight to Moore Clinical Trials
Respondent’s testimony regarding the . . . that same day . . . [T]he purpose of going to
GS’s and Respondent’s testimony could Moore Clinical Trials’’ was ‘‘to obtain the
be accurate. R.D., at 15 n.6. That is, the paperwork that the DIs requested and documents that Dr. Nichol told us was there, which
GS may be correct that DIs conducting received from Respondent during the would be inventory and the dispensing records’’);
inspections (‘‘we’’) typically ask inspection. The ALJ found that the GS’s see also id. at 478. The GS also rejected the notion
testimony in this context (and others) that the DIs had any interest in the patients’ names
registrants for DEA 222 forms, and addresses because the inspection was focused
inventories, and dispensing logs. Tr. 103 lacked credibility because the ALJ found on drugs, not people. Id. at 478.
(‘‘[i]t’s the same things we ask for every the GS’s testimony in conflict with The ALJ rejected the GS’s explanation and found
time’’). Indeed, the GS has conducted Respondent’s testimony. R.D., at 3–4, 15 Respondent’s ‘‘more credible’’ because (1) the stated
over 400 audits in her more than 28 n.17, 17 n.20, 19 n.25, 21 n.28, 34. In purpose of the inspection was to ensure compliance
its Exceptions, the Government with the MOA; (2) the inspection pursuant to the
MOA focused on recordkeeping, not drugs; (3)
15 In its Exceptions, the Government argues that disagreed with the ALJ’s credibility Respondent had advised DEA by letter (to which
the GS’s ‘‘use of the term ‘we’ . . . was intended DEA did not respond) in August 2012 that he could
to emphasize that more than one investigator had 17 The Government stated in its Exceptions that not provide patient names for a double blind study;
amozie on DSK3GDR082PROD with NOTICES1
requested the needed materials from Respondent.’’ ‘‘[t]he third investigator had been reassigned to and (4) the ALJ accepted that Respondent provided
ALJ Ex. 24, at 4. However, the record fails to reflect another DEA field office.’’ ALJ Ex. 24, at 4 n.4. the DIs with Respondent’s Exhibit U, which
this intent. However, nothing in the record explains why this Respondent represented to be his dispensing log.
16 I agree with the ALJ that it is possible, if not reassignment precluded the third DI from testifying R.D., at 15 n.16.
‘‘likely,’’ that the DIs reviewed but ‘‘may not have at the hearing. Assuming that the purpose of the inspection was
recognized Respondent’s Exhibit V as an initial 18 As discussed more fully infra, I also dismiss to determine whether Respondent’s recordkeeping
inventory because it contained far more information the Government’s first recordkeeping charge was in compliance with the MOA, the CSA, and
than would normally be contained in an initial regarding Respondent’s initial inventory for legal DEA regulations, that purpose is consistent with the
inventory.’’ R.D., at 17 n.20. reasons. Continued
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offered the GS’s testimony regarding the Accord id. Instead, I agree with the ALJ supplier copy, get sent to the supplier.’’
DIs visit there to establish the Show that the records provided by Ms. Id. at 45.
Cause Order’s allegation that Marshall were more likely worksheets When Respondent is placing an order,
Respondent had improperly maintained used as part of the Quintiles study to he retains the copy that states
his inventory or dispensing records at a reconcile differences between what the ‘‘PURCHASER’S Copy 3.’’ Id.; e.g., GX 9;
location other than his registered study patients entered into their RX S, at 5, 9–12, 16. For example, the
location. Upon arriving at Moore electronic monitors and the actual pill DEA 222 forms that Respondent
Clinical Trials, the DIs spoke with count. Id. at 20. Although the provided to the DIs during their
Kianna Marshall, who was an assistant worksheets include all of the data in inspection show that Fisher Clinical
to Moore Clinical Trials owner Greta Respondent’s dispensing log maintained Services (FCS) was the supplier of the
Moore. Id. at 56–57. The GS testified in his office, the worksheets contain drugs Respondent used in the study. Id.
that the DIs asked Ms. Marshall for the additional information not included in When Respondent ‘‘is shipping drugs
inventory and dispensing log for the Respondent’s dispensing log. Compare back to his supplier, Fisher [Clinical]
study so DEA ‘‘could complete an GX 11 with RX U.20 Services,’’ then his name would appear
accountability audit. And Kianna gave Neither the Government nor on the DEA 222 form as the supplier,
us a folder that had the dispensing Respondent called Ms. Marshall as a FCS would be the registrant, and
records in it. However, she did not have witness to establish what Respondent Respondent would retain ‘‘SUPPLIER’S
any inventory.’’ Id. at 57; see GX 11. may have told her about maintaining his Copy 1.’’ Tr. 48–50; GX 10; RX S, at 13–
Respondent denied that he failed to dispensing records at Moore Clinical 14. When filling out a supplier’s copy,
maintain his inventory and dispensing Trials or what she believed she had the supplier must fill out several fields
records in his office because he provided to the DIs. Thus, I find that the on the form, including the number of
represented that he kept them in his Government has provided insufficient packages, the size of the packages, the
office and presented them to the DIs evidence for me to find by a packages shipped, and the date when
during the inspection. See Tr. 278–79; preponderance of the evidence that they were shipped. Tr. 50; GX 10; RX S,
RX U; RX V. As already noted, the GS Respondent, in fact, failed to maintain at 13–14.
did not recall seeing (or saw but failed inventory and dispensing records at his
to recognize) the documents in Respondent’s Annotation of DEA 222
registered location. Forms
Respondent’s office as his inventory or
dispensing records (RX U and RX V), Respondent’s DEA 222 Forms In this case, Respondent provided
and it is unclear what the other DIs The GS testified that DEA 222 forms DEA with two DEA 222 forms in which
understood because they did not testify. are three-part forms that DEA registrants he was the ‘‘supplier’’ and FCS was the
Importantly, the fact that Ms. Marshall use to order controlled substances. See registrant because he was returning
provided the DIs with documents that Tr. 38, 42. Registrants request a book of unused drugs from the clinical trial back
she believed were responsive to the DIs’ DEA 222 forms in advance of ordering to FCS. Tr. 48–50, 253–54; see also GX
requests does not mean that those controlled substances, and then DEA 10; RX S, at 13–14. FCS had provided
documents were, in fact, Respondent’s sends back a book of DEA 222 forms— Respondent with a packing list that
dispensing records nor that Respondent each one preprinted with the registrant’s included instructions on how to fill out
intended to maintain his dispensing name, DEA registration number, the the DEA 222 forms as the supplier,
records at Moore Clinical Trials. Accord date he or she ordered the forms, and including instructions that he should
R.D., at 19 n.25 (‘‘there is no credible the schedules for which he or she is enter the number of kits shipped and
evidence before me that [what Ms. authorized to prescribe. See id. at 43– the date shipped. RX S, at 15; Tr. 376–
Marshall provided to the DIs] is in fact, 44. These forms have carbon paper in 77. However, Respondent left the
the Respondent’s dispensing records’’). between each copy so three parties can ‘‘Packages Shipped’’ and ‘‘Date
Likewise, the fact that the GS believed each get a copy. Id. at 38, 42. ‘‘One is Shipped’’ boxes next to the identified
that these documents could qualify as the purchaser’s copy, one is the kits blank in both DEA 222 forms in
Respondent’s dispensing records, or that supplier’s copy, and the third copy goes which Respondent was the supplier. RX
Ms. Marshall may have advised the DIs to DEA once the order is completed.’’ Id. S, at 15; Tr. 50. As a result, the GS
that they were Respondent’s dispensing at 44–45. The GS testified that testified that when these boxes are left
records, is not dispositive of whether ‘‘[Respondent] or his representatives blank, DEA ‘‘do[es] not know if th[e kits
they were, in fact, what Respondent fills out the supplier name, the date, and are] indeed what Dr. Nichol shipped
maintained as his dispensing records the requested drugs. And he tears off back.’’ Tr. 50. This negatively impacts
under the CSA and DEA’s regulations. that first copy, the purchaser’s copy. He DEA’s ability to conduct an audit of a
holds onto that. And then the second registrant, according to the GS, ‘‘because
GS’s explanation that the DIs’ focus was on drugs
two copies, the DEA copy and the the DEA 222 order form is a primary
and not patient names. The relevant recordkeeping record . . . as far as auditing purposes,
requirements focus on tracking the movement of
controlled substances (inventory, dispensing logs, 20 For this reason, the Government’s claim that it
these are the only documents we are
DEA 222 forms), not the identity of patients. could not complete an accountability audit at supposed to look at.’’ Id. at 51.
Moreover, as already noted, the more recent January Respondent’s registered address is unavailing. The In his testimony, Respondent
11, 2013 correspondence from DEA to Respondent worksheets obtained from Moore Clinical Trials admitted that he failed to properly
prior to the inspection asked when the Quintiles included everything contained in the dispensing
study would commence and where the study drugs
annotate the ‘‘Packages Shipped’’ and
logs maintained in Respondent’s office, which was
would be located (both of which relate to MOA sufficient to complete the audit. See Tr. 484. The Date Shipped’’ boxes:
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requirements) and not the identity or addresses of GS testified that the DIs had difficulty using the Q . . . Now, as you’re sitting here today,
Respondent’s study patients. See RX R, at 3. worksheets because ‘‘[t]here are numerous cross- do you realize that you completed this [first
Most importantly, I need not reach the question outs and circles and initials and changing of dates 222] form that you left off a date and the
of whether the GS’s explanation of why the DIs . . . it’s very hard to determine what’s coming in
visited Moore Clinical Trials was more or less and what’s going out.’’ Tr. 59. However, the GS
packets that were shipped back?
credible than Respondent’s because, as discussed conceded that having cross-outs or even confusing A Yes sir, I did. . . .
more fully infra, I reject the Government’s charge records does not violate DEA regulations, and they Q . . . So at least what [the GS] said about
that Respondent failed to maintain his inventory ultimately did not preclude the DIs from the return of this 222 form, that was correct,
and dispensing records at his registered location. completing their audit. Id. at 69–70. what she said; is that right?
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A Yes. . . . I did not fill out the date and Although her testimony was not substances to Respondent reflected on
I did not fill out the package quantity. always clear on this subject, the GS the supplier’s copy submitted into
Tr. 256–57; see also id. at 258 (‘‘Q Okay. ultimately testified on rebuttal that evidence by the Government. See Tr.
And again you made the same clerical Respondent (or someone in his office) 260; GX 13, at 1; RX S, at 16.
error on that [second 222] form? A I ‘‘presented’’ to the DIs ‘‘a folder with all The ALJ recommended that I make
did.’’). Accordingly, I find that of the 222s.’’ Tr. 507; see also id. at 290– the fact finding that the January 16,
Respondent failed to properly annotate 91 (Respondent testified that ‘‘[t]he DEA 2014 DEA 222 form ‘‘was available to
two DEA 222 supplier’s copy forms set 222s were kept in a hanging file folder the DEA investigators during the
forth in Government’s Exhibit 10 in a safe next to my office—or in my inspection’’ and that ‘‘[i]t is highly
because he failed to complete the office in a safe next to my desk. . . . probable that the alleged missing 222
‘‘Packaged Shipped’’ and Date Shipped’’ [Respondent] provide[d] that folder to Form was caught up in the carbon
entries. GX 10; RX S, at 13–14.21 the DEA investigators on the date of the copies of the other 222 Forms contained
onsite inspection.’’). Also during in the folder where the Respondent kept
Respondent’s Allegedly Missing DEA rebuttal, the GS acknowledged that his records.’’ R.D., at 22, 34. In other
222 Form Respondent had provided a folder to the words, the ALJ believed that the DIs
In its Show Cause Order, the DIs that not only included completed simply overlooked the January 16, 2014
Government alleged that Respondent DEA 222 forms reflected in Government DEA 222 form during the onsite
failed during the onsite inspection to Exhibits 9 and 10 but also included inspection. Id. at 34. I agree, and I find
‘‘voided and unused DEA 222s.’’ Id. at that it is more likely than not that the
provide a January 16, 2014 DEA 222
475. The GS stated that she was purchaser’s copy of the January 2014
form.22 ALJ Ex. 1, at 3. On the first day
uninterested in the ‘‘voided out and DEA 222 form was indeed in
of the hearing, the GS testified that
unused DEA 222s’’ and therefore only Respondent’s folder of DEA 222 forms
Respondent ‘‘produced for . . .
obtained ‘‘copies of the [completed] 222 on the date of the onsite inspection.23
inspection’’ ‘‘five DEA 222 order forms
for purchase’’ and ‘‘two DEA order order forms that were within our audit’’ The December 2014 Meeting
forms for returns back to the supplier,’’ period. Id.
Respondent introduced Respondent’s In December 2014, the lead DI
and that Government Exhibits 9 and 10 contacted Respondent to set up a
Exhibit S, which the ALJ accepted into
included copies of these seven forms. meeting with him. Tr. 237. This was the
evidence as the contents of the entire
See Tr. 39, 40–41, 52, 56 (‘‘the only folder of DEA 222 forms (22 pages) that first time the DIs had contacted
thing we received were a grand total of Respondent provided to the DIs during Respondent since the July 9, 2014 onsite
seven completed DEA form 222s’’); GXs the onsite inspection. See Tr. 214–15; inspection. See id. On December 16,
9–10. These exhibits did not include RX S. The exhibit included unused, 2014, two DIs—the GS and the lead DI—
Respondent’s purchaser’s copy of the voided, and completed DEA 222 forms met with Respondent and Ms. Buchanan
January 16, 2014 DEA 222 form. In (both Purchaser’s Copies and Supplier’s ‘‘to report on the July 9, 2014
addition, the GS testified that they did Copies) as well as a completed DEA 222 inspection.’’ ALJ Ex. 9, at 3; Tr. 481.
not ask Respondent why there were form from a previous drug study. Tr. During the meeting, the DIs advised
only five purchaser DEA 222 forms and 261, 475; RX S. Most significantly, Respondent that his ‘‘inventory was
not six such forms—even though the DIs Respondent’s exhibit included a copy of off.’’ Tr. 237. Respondent stated that he
knew that Respondent had made six the allegedly missing DEA 222 form offered to compare his inventory with
orders of controlled substances when related to the January 16, 2014 DEA’s inventory, but the DIs refused. Id.
they arrived for the onsite inspection. controlled substances shipment to at 238, 437, 507–08. The DIs also
Tr. 76, 505–06. Respondent testified Respondent. RX S, at 16. The GS did not discussed the accuracy of Respondent’s
that, had the DIs advised him that he recall seeing that form, and Respondent dispensing records and that Respondent
was missing any records, he would have did not recall to which DI he gave the had failed to provide the DIs with
endeavored to find and to provide them folder. Tr. 291 (‘‘Q Do you [Respondent] sufficient information to complete a
to the DIs. Id. at 236. remember which agent you gave these proper audit, which in turn required the
to? A ‘‘I do not.’’); id. at 475. DIs to go to Moore Clinical Trials to
21 During the hearing, the GS also testified to
After the pending Show Cause Order supplement the information. Id. at 439,
recordkeeping errors made by Respondent in filling was served on Respondent, Respondent 461. The DIs did not ask Respondent for
out the purchaser’s copies of the DEA 222 forms.
See, e.g., Tr. 47–48 (Respondent improperly used telephoned Mathilda Buchanan, an any records during the meeting. Id. at
three lines to order one drug when ‘‘[t]he Arkansas-licensed private investigator 500.
regulations state that when you are ordering a drug, with whom Respondent had worked On December 19, 2014, Respondent’s
it’s one drug per line’’). She stated that since 2006. Tr. 262, 417. Respondent attorney wrote a letter to the lead DI and
Respondent’s failure to accurately complete the
initial DEA 222 forms caused accountability errors
provided the same folder of DEA 222 to the GS on behalf of Respondent in
in the audit. Id. at 488. The Government did not, forms (Respondent’s Exhibit S) to Ms. response to the December 16, 2014
however, allege these errors in its Show Cause Buchanan that he had provided to the
Order or Prehearing Statements. Thus, I agree with DIs. See id. at 262. When Ms. Buchanan 23 For the same reason, I again need not reach the
the ALJ’s recommendation not to consider this question of the GS’s credibility regarding the
evidence in determining the sanction in this case.
examined the contents of the folder, she
allegedly missing DEA 222 form raised by the ALJ
R.D., at 3 n.2. testified that she discovered that the in his Recommended Decision and the Government
22 As noted supra in footnote 2, the Show Cause allegedly missing purchaser’s copy of in its Exceptions. R.D., at 34; ALJ Ex. 24, at 2 n.3,
Order erroneously referenced an August 28, 2013 January 2014 DEA 222 form was in fact 5. Specifically, because I find (as did the ALJ) that
DEA 222 form. The Government corrected the date within the folder but stuck between the DIs overlooked the DEA 222 form in question,
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of the allegedly missing DEA 222 form to January the GS could credibly testify that she did not see
16, 2014 in its May 12, 2016 Prehearing Statement
unused DEA 222 forms. Id. at 452–53, the form during the onsite inspection. Likewise, Ms.
and during Government counsel’s Opening 462; RX S, at 16. Moreover, the DEA 222 Buchanan could credibly testify that her
Statement at the administrative hearing. See ALJ Ex. form that Ms. Buchanan found was a (apparently more thorough) review of the folder of
7, at 8; Tr. 15. I further note that January 16, 2014 purchaser’s copy for an order of DEA 222 forms did uncover the allegedly missing
represents the shipping date, not the January 13, form. Accordingly, I find that there is no credibility
2014 date on which Respondent actually ordered
controlled substances dated January 13, issue regarding the allegedly missing DEA 222 form
the controlled substances. See GX 13, at 1; RX S, 2014, which corresponded to the because it is more likely than not that the testimony
at 16. January 16, 2014 shipment of controlled of both witnesses is accurate.
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meeting. RX X. The letter memorialized at 222); see also Hoxie, 419 F.3d at the Respondent’s registration.’’ R.D., at
Respondent’s understanding that DEA’s 482.24 28.
‘‘audit was not available to us’’ and Under the Agency’s regulation, ‘‘[a]t To be sure, the Agency’s case law
asked for ‘‘written documentation of any hearing for the revocation or contains some older decisions which
specific points you think are lacking so suspension of a registration, the can be read as giving more than nominal
we can do better.’’ Id. The letter also Administration shall have the burden of weight in the public interest
stated that records related to the proving that the requirements for such determination to a State Board’s
identification of patients ‘‘must be kept revocation or suspension pursuant to
at Moore Clinical Trials and are separate decision (not involving a
. . . 21 U.S.C. [§ ]824(a) . . . are
from the records at Dr. Nichol’s office recommendation to DEA) either
satisfied.’’ 21 CFR 1301.44(e). In this
which only contain the patients’ restoring or maintaining a practitioner’s
matter, I have considered all of the
identifying numbers.’’ Id. Respondent factors and concluded that the state authority to dispense controlled
never received a reply to his attorney’s Government’s evidence with respect to substances. See, e.g., Gregory D. Owens,
letter, and the Government filed its Factors Two and Four support the 67 FR 50461, 50463 (2002) (expressing
Show Cause Order on March 14, 2016. conclusion that Respondent has agreement with ALJ’s conclusion that
Tr. 443; ALJ Ex. 1. committed acts which render his the Board’s placing dentist on probation
‘‘registration inconsistent with the instead of suspending or limiting his
Discussion controlled substance authority ‘‘reflects
public interest.’’ 21 U.S.C. 823(f),
Under the Controlled Substances Act 824(a)(4). While I agree with the ALJ’s favorably upon [his] retaining his . . .
(‘‘CSA’’), ‘‘[a] registration pursuant to conclusion that a sanction is [r]egistration, and upon DEA’s granting
section 823 of this title to manufacture, appropriate, I find that the record of [his] pending renewal application’’);
distribute, or dispense a controlled supports a stronger sanction than what Scolaro, 67 FR at 42065 (concurring
substance . . . may be suspended or the ALJ recommended. with ALJ’s ‘‘conclusion that’’ state
revoked by the Attorney General upon board’s reinstatement of medical license
Factor One—The Recommendation of
a finding that the registrant . . . has the State Licensing Authority ‘‘with restrictions’’ established that
committed such acts as would render ‘‘[b]oard implicitly agrees that the
[its] registration under section 823 of The Government sought to revoke [r]espondent is ready to maintain a DEA
this title inconsistent with the public Respondent’s DEA registration based on registration upon the terms set forth in’’
interest as determined under such Factors Two, Four, and Five. However, its order). However, these cases cannot
section.’’ 21 U.S.C. 824(a)(4). In the case the ALJ considered Factor One as well be squared with the Agency’s
of a physician, who is deemed to be a in his Recommendation. R.D., at 27. I longstanding holding that ‘‘[t]he
practitioner, see id. § 802(21), Congress agree with the ALJ’s finding that the Controlled Substances Act requires that
directed the Attorney General to ASMB has not made a recommendation the Administrator . . . make an
consider the following factors in making to the Agency regarding whether
independent determination [from that
the public interest determination: Respondent’s DEA registration should
made by state officials] as to whether
(1) The recommendation of the appropriate be suspended or revoked in this case.
the granting of controlled substance
State licensing board or professional See id. The record only shows that the
ASMB suspended Respondent’s state privileges would be in the public
disciplinary authority.
medical license for six months based on interest.’’ Garrett Howard Smith, M.D.,
(2) The applicant’s experience in
dispensing or conducting research with his pre-signing of controlled substance 83 FR 18882, 18904 n.30 (2018) (quoting
respect to controlled substances. prescriptions, which his staff (who were Mortimer Levin, 57 FR 8680, 8681
(3) The applicant’s conviction record under not licensed to prescribe controlled (1992)); Lon F. Alexander, M.D., 82 FR
Federal or State laws relating to the substances) issued to patients outside 49704, 49724 n.42 (2017) (same).
manufacture, distribution, or dispensing of Indeed, neither Owens nor Scolaro even
Respondent’s presence and without
controlled substances. acknowledged the existence of Levin, let
(4) Compliance with applicable State, consulting him. The ALJ noted that the
Federal, or local laws relating to controlled ASMB reinstated Respondent’s medical alone attempted to reconcile the weight
substances. license after six months and stated that it gave the state board’s action with
(5) Such other conduct which may threaten ‘‘[t]he reinstatement of the Respondent’s Levin. Smith, 83 FR at 18904 n.30;
the public health and safety. medical license can be interpreted as a Alexander, 82 FR at 49724 n.42.
recommendation of the ASMB’’ under While in other cases, the Agency has
Id. § 823(f). Factor One. R.D., at 27 (citing Tyson D. given some weight to a Board’s action in
‘‘[T]hese factors are . . . considered Quy, M.D., 78 FR 47412, 47417 (2013); allowing a practitioner to retain his state
in the disjunctive.’’ Robert A. Leslie, Vincent J. Scolaro, D.O., 67 FR 42060,
M.D., 68 FR 15227, 15230 (2003). It is authority even in the absence of an
42064–65 (2002)). As a result, the ALJ
well settled that I ‘‘may rely on any one express recommendation, see Quy, 78
recommended that I find that ‘‘the
or a combination of factors, and may FR at 47417, the Agency has repeatedly
ASMB’s reinstatement of the
give each factor the weight [I] deem[] Respondent’s medical license only held that a practitioner’s retention of his
appropriate in determining whether’’ an weighs slightly in favor of not revoking or her state authority is not dispositive
application for registration should be of the public interest inquiry. See, e.g.,
denied. Id.; see also MacKay v. DEA, 24 In short, this is not a contest in which score
Smith, 83 FR at 18904 n.30; Alexander,
664 F.3d 808, 816 (10th Cir. 2011); is kept; the Agency is not required to mechanically 82 FR at 49724 n.42; Paul Weir
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Volkman v. DEA, 567 F.3d 215, 222 (6th count up the factors and determine how many favor Battershell, 76 FR 44359, 44366 (2011)
the Government and how many favor the registrant. (citing Edmund Chein, 72 FR 6580, 6590
Cir. 2009); Hoxie v. DEA, 419 F.3d 477, Rather, it is an inquiry which focuses on protecting
482 (6th Cir. 2005). Moreover, while I the public interest; what matters is the seriousness (2007), pet. for rev. denied, Chein v.
am required to consider each of the of the registrant’s or applicant’s misconduct. Jayam DEA, 533 F.3d 828 (D.C. Cir. 2008)).
factors, I ‘‘need not make explicit Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, Accordingly, I find that the ASMB’s
findings under a single factor can support the
findings as to each one.’’ MacKay, 664 revocation or suspension of a registration. MacKay,
reinstatement of Respondent’s state
F.3d at 816 (quoting Volkman, 567 F.3d 664 F.3d at 821. license is not dispositive of the public
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interest inquiry in this case, and I give 53 FR 15149, 15150 (1988) (‘‘It is a [T]he CSA and DEA regulations require
it no weight.25 violation of 21 CFR 1306.05(a) to pre- that a registrant take an actual physical count
sign prescriptions for controlled of the controlled substances on hand, and an
Factors Two and Four—The accurate actual count, as memorialized in
substances.’’). Most importantly, the
Respondent’s Experience in Dispensing either an initial or biennial inventory[. This]
Agency has held that pre-signing is essential in conducting an accurate audit.
Controlled Substances, or Conducting
Research With Respect to Controlled prescriptions ‘‘would be inconsistent Likewise, an accurate audit is essential in
Substances, and Compliance With with the public interest’’ under the CSA determining whether a registrant is
Applicable Laws Related to Controlled because such conduct ‘‘create[s] a maintaining complete and accurate records of
substantial risk that the drugs would be both the controlled substances he receives
Substances and those he ‘‘deliver[s] or otherwise
diverted and abused.’’ Singh, 81 FR at
Pre-Signed Prescriptions Allegation dispose[s] of.’’ 21 U.S.C. 827(a)(3). . . .
8248, 8249.
[G]enerally, it is diversion that results in
The Show Cause Order’s first charge As noted earlier, it is undisputed that recordkeeping irregularities and not the other
alleged that Respondent’s pre-signing of on August 17, 2016, the ASMB issued way around.
prescriptions for controlled substances a final order suspending Respondent’s Peter F. Kelly, D.P.M., 82 FR 28676,
violated 21 CFR 1306.05(a). Under the medical license for six months because 28692 n.41 (2017), pet. for rev. denied,
CSA, it is ‘‘unlawful for any person [to] he pre-signed prescriptions for Kelly v. DEA, No. 17–1175, 2018 WL
knowingly or intentionally . . . controlled substances. During the ASMB 3198774 (D.C. Cir. May 18, 2018).
manufacture, distribute, or dispense,26 hearing leading up to its final order, The Show Cause Order’s first
or possess with intent to manufacture, Respondent admitted in testimony that recordkeeping charge alleged that
distribute, or dispense, a controlled he pre-signed prescriptions in which he Respondent failed to maintain an initial
substance’’ ‘‘[e]xcept as authorized by’’ failed to write the name of the patient inventory of all controlled substances
the Act. 21 U.S.C. 841(a)(1). According on the prescription, the substance ‘‘in violation of 21 U.S.C. 827(a)(3) &
to the CSA’s implementing regulations, prescribed, and instructions for taking 842(a)(5) and 21 CFR 1304.11(b).’’ ALJ
‘‘[a]ll prescriptions for controlled the medication. In addition, Respondent Ex. 1, at 2. As a threshold matter, the
substances shall be dated as of, and admitted during the ASMB hearing that ALJ correctly noted ‘‘that it appears that
signed on, the day when issued and he permitted his office personnel, who the Government made an error because
shall bear the full name and address of were not licensed as physicians nor § 827(a)(3) requires a registrant to
the patient, the drug name, strength, authorized to prescribe medications maintain a dispensing record’’ and not
dosage form, quantity prescribed, under Arkansas law, to fill in the blanks an initial inventory as § 827(a)(1)
directions for use, and the name, on the prescription pad and distribute requires. See R.D., at 31 n.34. The ALJ
address and registration number of the them to patients without Respondent also noted accurately that the
practitioner.’’ 21 CFR 1306.05(a). being present. ‘‘Government, however, also correctly
The Agency has long held that pre- Thus, I agree with the ALJ’s cites to 21 CFR 1304.11(b).’’ Id. Section
signing prescriptions violates the CSA recommendation that I find (and I do so 1304.11(b) states that ‘‘[e]very person
and 21 CFR 1306.05(a). Arvinder Singh, find) that Respondent’s pre-signing of required to keep records shall take an
M.D., 81 FR 8247, 8248 (2016); Alvin prescriptions violated 21 CFR inventory of all stocks of controlled
Darby, M.D., 75 FR 26993, 26999 (2010) 1306.05(a). I also find that this conduct substances on hand on the date he/she
(‘‘DEA has long interpreted the CSA as constituted a serious violation of the first engages in the manufacture,
prohibiting the pre-signing of CSA and created a substantial risk that distribution, or dispensing of controlled
prescriptions.’’); Jayam Krishna-Iyer, the drugs would be diverted and substances.’’ Thus, I agree with the ALJ
M.D., 71 FR 52148, 52158, 52159 n.9 abused. Krishna-Iyer, 71 FR at 52159; that the Government intended to charge
(2006) (‘‘Respondent further violated Singh, 81 FR at 8249. I further find that Respondent with failing to maintain an
federal law and DEA regulations by Respondent violated federal law by initial inventory, despite its reference to
giving [his nurse] pre-signed giving the pre-signed prescription forms § 827(a)(3) instead of § 827(a)(1), and I
prescriptions and allowing him to issue to office personnel who lacked the further find that Respondent had
them to a patient [Respondent] had not authority to lawfully prescribe adequate notice of this charge.
attended to. . . . [T]his conduct of controlled substances under federal or Most importantly, the CSA and DEA’s
Respondent violated 21 CFR state law. See 21 CFR 1306.03(a); see regulations only require a practitioner
1306.05(a)’’), vacated on other grounds, also Krishna-Iyer, 71 FR at 52159. like Respondent to maintain an initial
249 Fed. Appx. 159 (11th Cir. 2007); Accordingly, the Government’s first inventory when he ‘‘first engages in . . .
Leslie, 68 FR at 15230–31; James Beale, charge of pre-signing prescriptions is dispensing controlled substances.’’ 21
sustained and supports a finding that CFR 1304.11(b); 21 U.S.C. 827(a)(1).
25 As to Factor Three, there is no evidence that
Respondent’s continued registration ‘‘After the initial inventory is taken, the
Respondent has been convicted of an offense under
either federal or Arkansas law ‘‘relating to the would be inconsistent with the public registrant shall take a new inventory of
manufacture, distribution or dispensing of interest. all stocks of controlled substances on
controlled substances.’’ 21 U.S.C. 823(f)(3). hand at least every two years’’—that is,
However, there are a number of reasons why even Recordkeeping Allegations
a ‘‘biennial inventory.’’ 21 CFR
a person who has engaged in criminal misconduct
may never have been convicted of an offense under The Show Cause Order sets forth five 1304.11(c); accord 21 U.S.C. 827(a)(1).
this factor, let alone prosecuted for one. Dewey C. recordkeeping charges based on DEA’s Thus, the CSA and DEA’s regulations
MacKay, 75 FR 49956, 49973 (2010), pet. for rev. July 4, 2014 on-site inspection of only required Respondent to maintain
denied, MacKay v. DEA, 664 F.3d at 822. The Respondent’s registered location. an initial inventory when Respondent
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Agency has therefore held that ‘‘the absence of such
a conviction is of considerably less consequence in ‘‘Recordkeeping is one of the CSA’s first engaged in dispensing controlled
the public interest inquiry’’ and is therefore not central features; a registrant’s accurate substances after obtaining his DEA
dispositive. Id. and diligent adherence to this obligation registration, even if the initial inventory
26 ‘‘The term ‘dispense’ means to deliver a
is absolutely essential to protect against was zero when Respondent
controlled substance to an ultimate user or research
subject by, or pursuant to the lawful order of, a
the diversion of controlled substances.’’ ‘‘commence[d] business.’’ 21 CFR
practitioner, including the prescribing . . . of a Paul H. Volkman, 73 FR 30630, 30644 1304.11(b). After that, the CSA and DEA
controlled substance.’’ 21 U.S.C. 802(10). (2008). As the Agency recently held: regulations required Respondent to
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maintain a biennial inventory. 21 U.S.C. the evidence that Respondent failed to controlled substances to ‘‘retain Copy 3
827(a)(1); 21 CFR 1304.11(c). provide the DIs with the relevant of each executed DEA Form 222 and all
Here, the Government’s first dispensing logs during the inspection. copies of unaccepted or defective forms
recordkeeping charge cannot be Furthermore, I agree with the ALJ’s with each statement attached.’’ See also
sustained as a matter of law because recommended finding (and I so find) 21 CFR 1304.04(a) (requiring registrants
Respondent was not legally required to that the dispensing log that Respondent to keep dispensing records and every
maintain an initial inventory as of the testified that he provided to the DIs (RX inventory for at least two years).
date of the alleged violation—i.e., at the U) was sufficient to rebut the However, here too, I have already found
time of the July 9, 2014 inspection. It is Government’s allegation that he failed to that the Government’s evidence is
undisputed that Respondent was maintain complete and accurate insufficient to support this charge.
dispensing controlled substances at dispensing records in violation of 21 Specifically, I found supra that it is
least as far back as 2006 under his U.S.C. 827(a)(3), 842(a)(5) and 21 CFR more likely than not that the purchaser’s
current DEA registration, and that 1304.21(a). See R.D., at 32–33. Thus, I copy of the allegedly missing January
Respondent has maintained, and timely do not sustain the Government’s second 2014 DEA 222 form was, in fact, within
renewed, his DEA registration ever recordkeeping charge. Respondent’s folder of DEA 222 forms
since. For related reasons, I cannot sustain that he presented to the DIs on the date
Although the CSA and DEA the Government’s fifth recordkeeping of the onsite inspection. Thus, I do not
regulations required Respondent to charge that Respondent failed to sustain the Government’s third
maintain an initial inventory when he maintain his inventory and dispensing recordkeeping charge.
first commenced the business of records at his registered location and The Government’s remaining (fourth)
dispensing controlled substances under maintained them instead at Moore recordkeeping charge alleged that
his current DEA registration for two Clinical Trials. The CSA requires that Respondent failed to properly annotate
years, he was only required to maintain registrants maintain ‘‘[a] separate two DEA–222 order forms (dated August
a biennial inventory thereafter. Yet the registration . . . at each principal place 15, 2013 and June 24, 2014) in violation
Government’s first recordkeeping charge of business or professional practice of 21 U.S.C. 842(a)(5) and 21 CFR
centers on whether Respondent where the applicant . . . dispenses 1305.13(b). The DEA 222 forms at issue
maintained an initial inventory when he controlled substances.’’ 21 U.S.C. in the fourth recordkeeping charge were
ordered controlled substances in 822(e). ‘‘In short, the requirements that suppliers’ copies, and DEA regulations
December 2012, not on when a practitioner be registered at each require suppliers to ‘‘record on Copies
Respondent first ‘‘commence[d the] principal place of professional practice 1 and 2 [of the DEA 222 form] the
business’’ of dispensing controlled where he dispenses controlled number of commercial or bulk
substances under his current DEA substances . . . [is one] of the containers furnished on each item and
registration. Thus, even if Respondent fundamental features of the closed the date on which the containers are
began dispensing controlled substances regulatory system created by the CSA.’’ shipped to the purchaser.’’ 21 CFR
for the first time as late as 2006—the Moore Clinical Trials, 79 FR at 40155. 1305.13(b). Here, as already noted,
earliest dispensing activity under However, as found above, the Respondent admitted that he failed to
Respondent’s current DEA registration Government has provided insufficient properly annotate on both forms (1) the
reflected in the record—he had no legal evidence for me to find by a date when he shipped controlled
obligation to maintain an initial preponderance of the evidence that substances back to FCS and (2) the
inventory beyond 2008. Instead, as Respondent, in fact, (1) maintained his amount shipped. Accordingly, I find
already noted, he was legally obligated dispensing records at Moore Clinical that the Government sustained its fourth
to maintain a biennial inventory Trials and (2) failed to maintain recordkeeping charge that Respondent
thereafter. However, the Government inventory and dispensing records at his failed to properly annotate two DEA 222
did not charge Respondent with failing registered location.28 See supra. Thus, I supplier’s copy forms pursuant to 21
to maintain an accurate biennial agree with the ALJ’s recommendation U.S.C. 842(a)(5) and 21 CFR 1305.13(b).
inventory in December 2012 or at the that I find (and I do so find) that the These violations support a finding that
time of the July 2014 inspection. Government failed to sustain the fifth Respondent’s continued registration
Accordingly, I do not sustain the recordkeeping charge. See R.D., at 36. would be inconsistent with the public
Government’s first recordkeeping The Government’s third interest under Factors Two and Four.
charge.27 recordkeeping charge alleged that
The Government’s second Respondent failed to provide a January Factor Five—Other Conduct Which
recordkeeping charge alleged that 2014 DEA 222 form during the May Threaten the Public Health and
Respondent failed to provide dispensing inspection. DEA regulation 21 CFR Safety
records to the DIs during the July 9, 1305.17(a) requires the purchaser of The Government argues that
2014 inspection. Both the CSA and DEA Respondent engaged in ‘‘other conduct’’
regulations require registrants to 28 The Government also alleged in its fifth
actionable under Factor Five because he
‘‘maintain, on a current basis, a recordkeeping charge that Respondent’s inventory
violated the MOA.29 Under the fifth
complete and accurate record of each and dispensing records were not ‘‘readily
retrievable’’ pursuant to 21 CFR 1304.04. Section
substance manufactured, received, sold 1304.04(g) requires registered individual 29 The Government also argued that Respondent’s
. . . or otherwise disposed of by him.’’ practitioners like Respondent to keep ‘‘records of alleged violations of the MOA should be considered
21 U.S.C. 827(a)(3); 21 CFR 1304.21(a). controlled substances in the manner prescribed in under Factor 2. ALJ Ex. 20, at 19. In addition, the
As found above, supra, the Government paragraph (f) of this section.’’ Section 1304.04(f), in Agency has held that ‘‘where an MOA term imposes
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turn, requires that ‘‘records of controlled substances the same requirements as a law or regulation, a
failed to establish by a preponderance of listed in Schedules III, IV, and V shall be violation of that term falls under Factor Four
maintained either separately from all other records because it is also a violation of a duly enacted law
27 In any event, as noted supra, I found that the of the registrant or in such form that the or regulation.’’ Roberto Zayas, M.D., 82 FR 21410,
Government failed to establish by a preponderance information required is readily retrievable from the 21422 n.26 (2017). To the extent that I have already
of the evidence that Respondent failed to provide ordinary business records of the registrant.’’ Here, addressed Respondent’s alleged recordkeeping
the DIs with an inventory consistent with the CSA the controlled substance used during the Quintiles violations under Factors Two and Four, I will not
and DEA’s regulations during the July 9, 2014 study was oxycodone, a Schedule II controlled consider them again under Factor Five because they
onsite inspection. substance. 21 CFR 1308.12(b)(1)(xiii). would not then constitute ‘‘other conduct’’ under
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public interest factor, the Agency Indeed, the history of Respondent’s (1) Abide by all Federal, State and local
considers ‘‘[s]uch other conduct which recordkeeping violations (and other statutes and regulations relating to controlled
may threaten the public health and violations) directly led to the MOA that substances.
(2) Make and keep (and make available for
safety.’’ 21 U.S.C. 823(f)(5). The Agency attempted to resolve them. As I already
inspection) records of all controlled
has clarified that Congress’ use of the noted supra, the GS testified that DEA substances that he prescribes, dispenses, and
word ‘‘may’’ in Factor Five means that first became aware of Respondent as administers at his registered location
it intended the Agency to consider part of its 2011 investigation of his pursuant to 21 CFR 1306.05(a) and 1304.21.
conduct which creates a probable or recordkeeping (and other) violations (3) Make and keep a legible log of all
possible (and not necessarily an actual) regarding the earlier NKRT–118 study Schedule II–V controlled substances that he
threat to public health and safety. Mark he conducted with Moore Clinical prescribed and provide that to DEA on a
P. Koch, D.O., 79 FR 18714, 18735 Trials. Tr. 28–29. This 2011 quarterly basis for three years.
investigation not only led to the 2011 (4) Retain his prescribing, administering
(2014) (collecting cases); ChipRX, L.L.C., and dispensing records at his registered
d/b/a City Center Pharmacy, 82 FR Show Cause Order against Respondent;
location.
51433, 51438 n.10 (2017) (‘‘Factor Five it also led to a separate 2011 Show (5) Notify DEA if he will prescribe,
does not require that the Government Cause Order against Moore Clinical dispense, or administer controlled substances
prove an actual threat to public health Trials. However, unlike Respondent, at any location other than his registered
or safety’’). Thus, the Government is not who resolved the Show Cause Order location or the Springhill Surgery Center
required to establish that a specific against him by entering into an MOA, where he routinely administers drugs during
violation of the MOA by Respondent the Order against Moore Clinical Trials a scheduled medical procedure.
resulted in a final published order. (6) Order, receive, administer, and
created an actual threat to the health
Moore Clinical Trials, L.L.C., 79 FR dispense controlled substances only at his
and safety of the public under Factor registered location.
Five. 40145 (2014).
Most importantly, in Moore Clinical (7) Notify DEA in advance of commencing
DEA has long held that a registrant’s any drug study involving controlled
Trials, the Agency found that
failure to comply with the terms of an substances additional to the NKTR–118
Respondent committed recordkeeping study.
MOA can constitute acts which render and other violations related to the
his registration inconsistent with the NKRT–118 study that correspond to the GX 7, at 2–4. It is undisputed that
public interest. Erwin E. Feldman, D.O., terms of the MOA. For example, the Respondent did not violate the MOA’s
76 FR 16835, 16838 (2011) (revoking Agency noted the ALJ’s findings that third and fifth conditions. See Tr. 92,
practitioner’s registration under Factors Respondent’s ‘‘documents’’ ‘‘were 93, 117–19.
Two and Five for violating MOA) deficient and that the order forms for The Government argued that the same
(internal citation omitted); cf. Fredal Schedule II controlled substances five alleged recordkeeping violations
Pharmacy, 55 FR 53592, 53593 (1990) (DEA–222) were lacking’’ in connection also violated the MOA’s first, second,
(revoking pharmacy’s registration for with the NKRT–118 study. Id. at 40147 fourth, and sixth conditions.32 See R.D.,
violations of its MOA ‘‘which threatens (internal quotations omitted). The 32 During the hearing, the Government alleged
the public health and safety’’). This is so Agency also noted the ALJ’s finding that that Respondent violated the MOA’s seventh
even if the violation of the MOA does Respondent had improperly transported condition for failing to notify DEA in advance of
not establish a violation of the CSA or controlled substances to Moore Clinical commencing the Quintiles Study set forth in the
its implementing regulations. Feldman, Trials’ location where he was not CTA. See Tr. 93–94, 119–21, 181–82; GX 7, at 3 (‘‘if
76 FR at 16838. In its Proposed Findings [Respondent] is asked to participate in additional
registered to dispense them in drug studies involving controlled substances, he
of Fact and Conclusions of Law, the connection with that study. Id. The will notify DEA in advance of commencing the
Government argued that this case is then-Administrator also found that study’’). Although the ALJ questioned whether the
similar to OTC Distribution Company, Respondent’s DEA 222 forms related to Government had provided sufficient notice to
where the Agency revoked the Respondent that the Government would rely on a
the NKRT–118 study did not properly violation of this MOA condition, the ALJ proceeded
registration of a distributor for ‘‘its indicate the date the drugs were to analyze the issue and recommended that I find
inability or unwillingness to fully received and the quantity received. Id. that Respondent did not violate this MOA
comply with its recordkeeping and at 40151, 40156. The then- condition. See R.D., at 10 n.11.
report obligations under the MOA.’’ ALJ Administrator concluded that ‘‘the I agree (and I do so find) that Respondent did not
Ex. 20 at 20–21 (quoting OTC violate this MOA condition for the following
record clearly establishes that Dr. reasons. Although the GS testified that ‘‘[i]n DEA’s
Distribution Company, 68 FR 70538, Nichol violated both the separate mind’’ the study commenced when Respondent
70542 (2003)). The Government further registration provision and DEA placed his first order for controlled substances
argued that, ‘‘[a]s in OTC, the recordkeeping requirements.’’ Id. at related to the study on December 3, 2012 (Tr. 93–
Respondent here has demonstrated, over 94, 121), the Government has identified no
40155. The DEA therefore entered into provision of the CSA, DEA’s regulations or Agency
a period of years, an unwillingness or the MOA (which expressly referenced precedent supporting this statement. Moreover, the
inability to follow DEA’s recordkeeping the NKRT–118 study) with Respondent MOA did not define what constituted ‘‘commencing
requirements even after being placed as an intermediary step to get the study.’’ Absent additional evidence of the
under an MOA with strict monitoring parties’ intent when entering into the MOA, I find
Respondent into compliance and to that the Quintiles Study commenced when
requirements.’’ ALJ Ex. 20 at 21.30 address Respondent’s recordkeeping Respondent first dispensed controlled substances.
and separate registration violations If, hypothetically, Respondent had ordered and
Factor Five. See id. at 21427 n.40. However, I will related to the NKRT–118 study received controlled substances for the Quintiles
consider whether the proved recordkeeping Study, enrolled study patients for it, but never
violations already discussed are sufficient evidence described and found by the Agency in ultimately dispensed the controlled substances to
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to establish a violation of the MOA under Factor Moore Clinical Trials.31 the enrolled study patients, then the study still
Five. Respondent agreed to meet the would not have commenced.
30 In his Recommendation, the ALJ disagreed with Here, on December 31, 2012, Respondent notified
following seven conditions set forth in
the Government’s characterization of Respondent’s the GS (by letter from his attorney) that he was
past recordkeeping conduct because ‘‘the
the MOA: participating in the study. As noted supra, I found
Respondent does not have a history of failing to that Respondent began enrolling patients for the
keep the required records.’’ R.D., at 39. However, in published Agency precedent. See, e.g., Moore Quintiles study in January 2013, and that he first
as discussed more fully infra, Respondent’s history Clinical Trials, 79 FR at 40151, 40155. dispensed controlled substances to study patients
of recordkeeping violations is already documented 31 See supra footnote 12. Continued
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at 40; Tr. 91–93, 178–79. I discussed all that Respondent’s registration ‘‘would Pharmaceuticals, Inc., 72 FR 36487,
of the recordkeeping allegations in my be inconsistent with the public 36504 (2007). Obviously, the
analysis of Factors Two and Four, interest.’’ 21 U.S.C. 823(f). egregiousness and extent of an
wherein I concluded that the applicant’s misconduct are significant
Sanction
Government proved only one factors in determining the appropriate
recordkeeping violation by a Where, as here, ‘‘the Government has sanction. See Jacobo Dreszer, 76 FR
preponderance of the evidence— proved that a registrant has committed 19386, 19387–88 (2011) (explaining that
Respondent’s failure to properly acts inconsistent with the public a respondent can ‘‘argue that even
annotate two supplier DEA 222 forms. interest, a registrant must ‘‘ ‘present though the Government has made out a
With respect to Factor Five, I also find sufficient mitigating evidence to assure prima facie case, his conduct was not so
that these two recordkeeping failures the Administrator that [he] can be egregious as to warrant revocation’’);
violated the MOA’s first condition that entrusted with the responsibility carried Volkman, 73 FR at 30644; see also
Respondent abide by all Federal by such a registration.’ ’’thnsp;’’ Battershell, 76 FR at 44369 (imposing
regulations because (as already noted) Medicine Shoppe-Jonesborough, 73 FR six-month suspension, noting that the
failing to properly annotate a supplier’s 364, 387 (2008) (quoting Samuel S. evidence was not limited to security and
DEA 222 form violates 21 CFR Jackson, 72 FR 23848, 23853 (2007) recordkeeping violations found at first
1305.13(b). Thus, I agree with the ALJ’s (quoting Leo R. Miller, 53 FR 21931, inspection and ‘‘manifested a disturbing
recommendation that I find (and I do 21932 (1988))). ‘‘Moreover, because pattern of indifference on the part of
find) that Respondent violated the MOA ‘past performance is the best predictor [r]espondent to his obligations as a
based on his failure to properly annotate of future performance,’ ALRA Labs, Inc. registrant’’); Gregory D. Owens, 74 FR
two supplier DEA 222 forms. R.D., at 40. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), 36751, 36757 n.22 (2009).
I also agree with the ALJ’s [DEA] has repeatedly held that where a So too, the Agency can consider the
recommendation that the analysis of registrant has committed acts need to deter similar acts, both with
whether the MOA violation was inconsistent with the public interest, the respect to the respondent in a particular
sufficient to establish a violation of registrant must accept responsibility for case and the community of registrants.
Factor Five does not stop here. Under its actions and demonstrate that it will See Gaudio, 74 FR at 10095 (quoting
the MOA, Respondent agreed that ‘‘any not engage in future misconduct.’’ Southwood, 71 FR at 36503). Cf.
violations of the Agreement may result Medicine Shoppe, 73 FR at 387; see also McCarthy v. SEC, 406 F.3d 179, 188–89
in the initiation of proceedings to Jackson, 72 FR at 23853; John H. (2d Cir. 2005) (upholding SEC’s express
revoke or immediately suspend and Kennedy, 71 FR 35705, 35709 (2006); adoption of ‘‘deterrence, both specific
revoke his DEA Certificate of Prince George Daniels, 60 FR 62884, and general, as a component in
Registration.’’ GX 7, at 3. However, DEA 62887 (1995). See also Hoxie, 419 F.3d analyzing the remedial efficacy of
agreed that it would ‘‘not seek to revoke at 483 (‘‘admitting fault’’ is ‘‘properly sanctions’’).
Dr. Nichol’s DEA registration . . . consider[ed]’’ by DEA to be an After considering (1) Respondent’s
unless Dr. Nichol substantially violates ‘‘important factor[ ]’’ in the public unlawful pre-signing of prescriptions
this Agreement or unless [he] commits interest determination). that his unlicensed staff members then
additional acts that constitute grounds An applicant’s acceptance of issued to patients without further
under 21 U.S.C. 823(f) and 824(a).’’ Id. responsibility must be unequivocal. See consulting Respondent and (2)
at 3–4 (emphasis added). In other Alexander, 82 FR at 49728 (collecting Respondent’s failure to properly
words, DEA agreed not to seek to revoke cases). Also, an applicant’s candor annotate two supplier DEA 222 forms,
Respondent’s DEA registration unless he during both an investigation and the the ALJ recommended a sanction of
‘‘substantially violates’’ the MOA. Here, hearing itself is an important factor to be imposing restrictions on Respondent’s
I agree with the ALJ’s recommendation considered in determining both whether DEA registration based solely on the
that I find (and I do find) that he has accepted responsibility as well as sustained recordkeeping violation. R.D.,
Respondent’s failure to properly the appropriate sanction. Michael S. at 41–46. He did not recommend that I
complete two supplier DEA 222 forms Moore, 76 FR 45867, 45868 (2011); impose a sanction of either suspension
alone is insufficient to establish that Robert F. Hunt, D.O., 75 FR 49995, or revocation. See id. As set forth more
Respondent ‘‘substantially violate[d]’’ 50004 (2010); see also Jeri Hassman, 75 fully below, I disagree with the ALJ’s
the MOA. R.D., at 40 (‘‘I find that the FR 8194, 8236 (2010) (quoting Hoxie, recommended sanction.
violation of the 2012 MOA, of 419 F.3d at 483 (6th Cir. 2005) (‘‘Candor
during DEA investigations, regardless of Pre-Signing Prescription Misconduct
improperly completing the two supplier
222 Forms, standing along is not a the severity of the violations alleged, is With respect to Respondent’s pre-
significant violation of the 2012 MOA considered by the DEA to be an signing of prescriptions, the ALJ
itself.’’) (emphasis in original). important factor when assessing recommended that I do not rely on this
Accordingly, I find that Respondent’s whether a physician’s registration is misconduct as a basis for any sanction
non-substantial violation of the MOA consistent with the public interest[.]’’)), whatsoever. Id. at 42–43 (recommending
nominally supports a finding that pet. for rev. denied, 515 Fed. Appx. 667 against relying upon ‘‘Respondent’s pre-
Respondent’s continued registration (9th Cir. 2013). signing of prescriptions as a basis for
would be inconsistent with the public While a registrant must accept revocation or sanction’’). The ALJ
interest under Factor Five. responsibility for his misconduct and identified five mitigating actions or
Having considered all the factors demonstrate that he will not engage in factors related to Respondent’s unlawful
above, I hold that the Government has future misconduct in order to establish pre-signing of prescriptions to support
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established its prima facie case showing that his registration would be consistent his Recommendation: (1) Respondent
with the public interest, DEA has ‘‘obtained high quality prescription
on February 18, 2013. Thus, I find that Respondent repeatedly held that these are not the pads that make reproduction difficult,
did not violate the MOA’s seventh condition only factors that are relevant in and he writes all of his prescriptions by
because he notified DEA that he was asked to
participate in the Quintiles Study on December 31,
determining the appropriate disposition hand’’ ‘‘[t]o prevent forgery of his
2012, in advance of commencing the study on of the matter. See, e.g., Joseph Gaudio, prescriptions;’’ (2) ‘‘his prescription
February 18, 2013. 74 FR 10083, 10094 (2009); Southwood pads produce a duplicate copy, which
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the Respondent keeps in the medical signing of prescriptions to warrant no The Agency has long held that pre-
file’’ ‘‘[t]o increase the likelihood that he sanction for his unlawful conduct. signing prescriptions ‘‘would be
can identify his prescriptions;’’ (3) he In addition, the ALJ’s reliance on inconsistent with the public interest’’
‘‘began providing the DEA with copies DEA’s renewals of Respondent’s under the CSA because such conduct
of his prescriptions, as required by the registration in 2010 and 2013 after the ‘‘create[s] a substantial risk that the
MOA;’’ (4) ‘‘the DEA has renewed his ASMB restored Respondent’s state drugs would be diverted and abused.’’
registration multiple times since his license in 2007 as a mitigating factor is E.g., Singh, 81 FR at 8248, 8249. And as
medical license was restored;’’ and (5) misplaced because it overlooks the I noted earlier, Respondent’s pre-signing
he ‘‘had not been cited for any chronology of DEA’s investigation of of prescriptions constituted a serious
prescription violations in the past ten Respondent. The GS testified that DEA violation of the CSA—not only because
years’’ and ‘‘the amount of time that has first became aware of Respondent as it created a substantial risk that the
passed since.’’ Id. Based on these five part of its 2011 investigation of his drugs would be diverted and abused but
factors and the fact that Respondent had violations regarding the NKRT–118 also because Respondent gave the pre-
accepted responsibility for unlawfully study he conducted with Moore Clinical signed prescription forms to office
pre-signing prescriptions, the ALJ found Trials. DEA’s 2011 investigation led to personnel who lacked the authority to
that Respondent had taken sufficient the 2011 Show Cause Order against lawfully prescribe controlled substances
‘‘mitigating actions’’ and ‘‘efforts at Respondent. The 2011 Order included under federal or state law. See 21 CFR
remediation’’ that this unlawful conduct DEA’s allegation that Respondent 1306.03(a); see also Krishna-Iyer, 71 FR
should not be the basis for any sanction unlawfully pre-signed prescriptions and at 52159.
whatsoever. Id. at 42–43. that the ASMB suspended him in 2006 Unlike the ALJ, I find that the
Although I agree with the ALJ that for this conduct. Prior to 2011, there is Agency’s interest in deterring this
Respondent accepted responsibility for no evidence in the record that DEA was misconduct in the future both on the
unlawfully pre-signing prescriptions, I aware of Respondent’s misconduct— part of Respondent as well as the
disagree that there exists sufficient thereby making any renewals of community of registrants supports a
mitigating evidence to warrant no Respondent’s DEA registration prior to sanction. The ASMB imposed a six-
sanction at all for Respondent’s pre- 2011 (including the 2010 renewal) month suspension of Respondent’s state
signing of prescriptions. For example, irrelevant. license for unlawfully pre-signing
Respondent’s decision to handwrite his Moreover, Respondent and DEA prescriptions. Although there is
prescriptions on ‘‘high quality attempted to resolve the 2011 Show precedent in the context of pre-signing
prescription pads’’ that ‘‘produce a Cause Order’s allegations by entering prescriptions for imposing a sanction to
duplicate copy’’ is an admirable effort to into the 2012 MOA. Once Respondent’s match the ASMB’s sanction, cf. Walter
prevent prescription forgery. However, DEA registration came up for renewal in S. Gresham, M.D., 57 FR 44213, 44214–
the ALJ failed to explain how these 2013, DEA renewed it because at that 15 (1992) (imposing same sanction
actions intended to prevent forgery of time DEA believed Respondent was against respondent who unlawfully pre-
Respondent’s signature on a complying with the CSA, DEA signed prescriptions as Georgia
prescription (the ALJ’s first two factors) regulations, and the 2012 MOA. DEA imposed), I believe Respondent’s
would remediate or prevent Respondent did not learn that Respondent had acceptance of responsibility for
from again pre-signing prescriptions violated the 2012 MOA until after DEA’s unlawfully pre-signing prescriptions,
with his authentic signature in the July 2014 onsite inspection of and the lack of any evidence that
future. It is manifest that a practitioner, Respondent’s registered address. As a Respondent has engaged in this same
whether he or she pre-signs a ‘‘high result of Respondent’s violation of the misconduct since 2006, warrants a
quality’’ or a ‘‘low-quality’’ prescription MOA, DEA was entitled to issue a new lesser sanction than that imposed by the
pad, is still the one signing the Show Cause Order against Respondent, ASMB. Accordingly, I find that
prescription in a case like this one which it issued on March 14, 2016, that suspending Respondent’s DEA
involving unlawful pre-signing of included the allegations set forth in the registration for one month is what is
prescriptions. earlier 2011 Show Cause Order. Thus, I necessary to protect the public interest.
Here, there is no allegation that find that the fact that DEA renewed As for the issue of specific deterrence,
anyone forged Respondent’s signature Respondent’s registration in 2010 and a suspension of Respondent’s
on prescriptions. It is Respondent’s pre- 2013 does not constitute evidence registration for one month is not a bar
signing of his own signature on mitigating Respondent’s unlawful pre- on his practice, much less a permanent
prescriptions, not forgery, that is the signing of prescriptions. bar. And regarding general deterrence,
basis for Respondent’s unlawful However, I do agree with the ALJ that those members of the regulated
prescription conduct at issue in this the final factor he identified constitutes community who contemplate
case. Thus, I find Respondent’s efforts to mitigating evidence. Specifically, I find unlawfully pre-signing prescriptions
prevent forgery would not and do not that the amount of time that has passed need to know that the Agency takes
mitigate Respondent’s unlawful pre- since Respondent unlawfully pre-signed such misconduct—and the grave risk of
signing of prescriptions. prescriptions is mitigating evidence diversion that it creates—seriously and
The ALJ’s reliance on Respondent because he has not repeated this that there will be concomitantly serious
providing DEA with copies of his particular misconduct since 2006. Koch, consequences if they choose to engage
prescriptions as mitigating evidence (the 79 FR at 18736 (‘‘time is certainly an in such misconduct. This interest would
ALJ’s third mitigating factor) is similarly appropriate factor to be considered’’ be compelling even if it was not the case
unavailing. As the ALJ concedes, where ‘‘ ‘during that time [the] that the nation faces an epidemic of
amozie on DSK3GDR082PROD with NOTICES1
Respondent only provided copies of his Respondent has learned from his past opioid abuse.
prescriptions to DEA because the MOA mistakes’ ’’) (quoting Leonardo V. Lopez,
required him to do so. See R.D., at 42. M.D., 54 FR 36915, 36915 (1989)). And Recordkeeping Misconduct
I find that the fact that Respondent it is this mitigating evidence, along with With respect to the recordkeeping
complied with this MOA requirement the fact that Respondent accepting violations, the ALJ stated that this
does not constitute sufficient mitigating responsibility, that I consider in ‘‘violation [of DEA’s regulations] is
evidence regarding his unlawful pre- imposing a sanction. significant because without knowing the
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![47368 Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices
quantity of controlled substances Respondent’s history of recordkeeping the order forms for Schedule II
shipped back to Fisher, it is impossible violations: controlled substances (DEA–222) were
to conduct an accurate audit of the The Government’s arguments are puzzling lacking’’ in connection with the NKRT–
Respondent’s controlled substances in this regard because the Respondent was 118 study. Moore Clinical Trials, 79 FR
using his records, and it is his records not cited for any recordkeeping violations in at 40147 (internal quotations omitted).
that are the subject of these the 2011 [Show Cause Order], and in its post- The then-Administrator also found that
proceedings.’’ R.D., at 43. The ALJ hearing brief, the Government does not cite Respondent’s DEA 222 forms related to
recommended that I find that to any recordkeeping violations that occurred the NKRT–118 study did not properly
‘‘Respondent’s recordkeeping violation prior to the current allegations. . . . indicate the date the drugs were
Respondent does not have a history of
to be egregious. It was egregious because failing to keep the required records. The
received and the quantity received. Id.
it prevented the DEA from being able to Government’s attempt to paint Respondent’s at 40151, 40156. Most significantly, this
use the Respondent’s own records to current violations as a continuation of the type of recordkeeping violation
conduct an accurate audit of the DEA’s concerns that prompted the issuance involving DEA 222 forms—failure to
controlled substances for which the of the 2011 OSC is disingenuous at best! . . . properly record the date and quantity of
Respondent was accountable while he Here, . . . there is no evidence that the controlled substances—is the same type
served as the principal investigator in Respondent has a history of improperly of recordkeeping violation that
the controlled drug study.’’ Id. at 45. completing 222 Forms, either as a purchaser Respondent committed in this case.
or as a supplier.
Nevertheless, the ALJ found that Thus, contrary to the ALJ’s conclusion,
Respondent can be entrusted with a Id. at 44 (emphasis in original). Respondent in fact ‘‘has a history of
DEA registration and recommended that It is unclear why the ALJ was improperly completing 222 Forms.’’ See
I only place restrictions upon unaware of Respondent’s history of R.D., at 44.
Respondent’s registration, rather than recordkeeping violations, including a The then-Administrator concluded in
revoking or suspending his registration. history of improperly completing DEA Moore Clinical Trials that ‘‘the record
Id. at 42–43, 45–46. Although the ALJ 222 Forms, in light of Moore Clinical clearly establishes that Dr. Nichol
acknowledged that Respondent ‘‘has not Trials. As I noted earlier, Respondent’s violated both the separate registration
taken any specific remedial steps to history of recordkeeping (and other) provision and DEA recordkeeping
address his improper completion of violations was referenced in the record. requirements.’’ 79 FR at 40155. The
supplier 222 forms,’’ the ALJ reasoned In its Proposed Findings filed post- DEA therefore entered into the MOA
that Respondent ‘‘now knows how to hearing, the Government referenced the (which expressly referenced the NKRT–
properly complete a 222 form when he GS’s testimony that she first became 118 study) with Respondent as an
is a supplier, and he has stated that in aware of Respondent after receiving an intermediary step to get Respondent
the future he will fill out the form application for a DEA registration from into compliance and to address
correctly.’’ Id. at 43 (citing Tr. 257). In Moore Clinical Trials, and that this Respondent’s recordkeeping and
short, the ALJ believed that application led to a DEA investigation of separate registration violations related
Respondent’s ‘‘egregious’’ and both Moore Clinical Trials and to the NKRT–118 study described and
‘‘significant’’ recordkeeping violations Respondent in 2011 that found found by the Agency in Moore Clinical
nonetheless warranted only the recordkeeping violations. See ALJ Ex. Trials.
imposition of restrictions on (and not 20, at 4. The ALJ’s finding that Respondent’s
suspension or revocation of) The Government also referenced the recordkeeping violation in this case is
Respondent’s DEA registration because GS’s testimony that Moore Clinical not ‘‘a minor oversight’’ but an
it was the first time Respondent had Trial’s DEA application was denied. Id. ‘‘egregious’’ and ‘‘significant’’ violation,
committed recordkeeping violations. The ALJ even acknowledged this denial combined with Respondent’s history of
In contrast, the Government argued in in his Recommendation. R.D., at 3. recordkeeping violations, requires a
its Proposed Findings that Respondent Although the Government could have stronger sanction than what the ALJ
‘‘has demonstrated, over a period of better assisted the ALJ by directing him recommended. In that vein, I find that
years, an unwillingness or inability to to a case citation to the Agency’s the Agency’s interest in deterring this
follow DEA’s recordkeeping decision, it does not change the fact that misconduct in the future both on the
requirements.’’ ALJ Ex. 20, at 21. The Moore Clinical Trials—like all other part of Respondent as well as the
Government further argued that final agency actions issued by my community of registrants supports
Respondent’s ‘‘recordkeeping violations office—was an Agency decision imposing a two-part sanction. Although
that prompted DEA’s 2011 Order to published in the Federal Register. As the ALJ’s recommended restrictions on
Show Cause, which was settled with the such, Moore Clinical Trials compels a Respondent’s registration could be a
2012 MOA, and his continued finding that Respondent has a history of sufficient deterrent for a registrant who
violations of these same recordkeeping recordkeeping violations. lacked a history of recordkeeping
requirements,’’ ‘‘warranted’’ As already noted, the Agency found violations, that is not this case. Here, the
‘‘revocation.’’ Id. at 19. in Moore Clinical Trials that Agency already attempted to address
In his Recommendation, the ALJ Respondent committed both separate Respondent’s prior recordkeeping
disagreed because he believed that ‘‘the registration and recordkeeping violations by imposing the restrictions
Respondent does not have a history of violations in connection with the (rather than suspending or revoking his
failing to keep the required records.’’ NKRT–118 study Respondent DEA registration) set forth in the MOA.
R.D., at 39. The ALJ reached this conducted with Moore Clinical Trials To simply impose more restrictions after
conclusion because ‘‘Respondent that, not coincidentally, correspond to Respondent again committed
amozie on DSK3GDR082PROD with NOTICES1
entered into an MOA with the DEA’’ the terms of the MOA. Moore Clinical recordkeeping violations would be no
‘‘[t]o resolve the September 2011 [Show Trials even documented Respondent’s sanction at all in this case. See Mark De
Cause Order],’’ and ‘‘[n]owhere in the history of recordkeeping violations in La Lama, P.A., 76 FR 20011, 20020
2011 [Show Cause Order] are connection with DEA 222 forms. For (2011) (‘‘granting Respondent’s
recordkeeping violations.’’ Id. example, the Agency noted the ALJ’s application subject to the restrictions
Elsewhere, the ALJ contested the findings that Respondent’s proposed by the ALJ, which do no more
Government’s characterization of ‘‘documents’’ ‘‘were deficient and that than replicate the conditions imposed
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![Federal Register / Vol. 83, No. 182 / Wednesday, September 19, 2018 / Notices 47369
by the MOA, amounts to no sanction at 3. That restrictions one and two, above, especially on the estimated public
all. In short, adopting the ALJ’s will not be lifted, even after four years, until burden or associated response time,
proposed sanction would send the the Respondent has completed a course in suggestions, or need a copy of the
wrong message to both Respondent . . . controlled substance recordkeeping, a course proposed information collection
in controlled substance storage, and a course
as well as other applicants/registrants’’). in the administration of controlled
instrument with instructions or
For this reason, I find that suspending substances, and provides the DEA with additional information, please contact
Respondent’s DEA registration for one evidence of completion of these courses. Elizabeth Ann Carson, Statistician,
month (concurrently with the sanction I These courses may not be used to meet any Bureau of Justice Statistics, 810 Seventh
imposed for Respondent’s unlawful pre- continuing medical education requirement. Street NW, Washington, DC 20531
signing of prescriptions) is necessary to 4. That prior to renewal of the (email: elizabeth.carson@usdoj.gov;
protect the public interest. In addition, Respondent’s DEA registration, he sign a telephone: 202/616.3496).
I impose the same restrictions to document consenting to inspections by DEA
SUPPLEMENTARY INFORMATION: Written
Respondent’s registration as proposed personnel of his medical practice without the
need for DEA personnel to obtain an comments and suggestions from the
by the ALJ, and I direct that these administrative inspection warrant prior to public and affected agencies concerning
restrictions—set forth infra—are set to conducting an inspection. By the terms the proposed collection of information
begin at the conclusion of Respondent’s contained in the consent form, the consent are encouraged. Your comments should
one-month suspension. shall be valid for four years from the date his address one or more of the following
The Agency’s interests in both current renewal application for a DEA four points:
specific and general deterrence support registration is approved. This consent form is
to be delivered to the Respondent’s local
—Evaluate whether the proposed
this two-part sanction. As for the
DEA Field Office. collection of information is necessary
Agency’s interest in specific deterrence,
5. That prior to renewal of the for the proper performance of the
and as already noted, the one-month
Respondent’s DEA registration, he sign a functions of the Bureau of Justice
suspension of his DEA registration is
document consenting to the conditions set Statistics, including whether the
not a bar on his practice, much less a forth in Paragraphs one and two above and information will have practical utility;
permanent bar. In addition, the acknowledging his understanding that his —Evaluate the accuracy of the agency’s
restrictions that I impose in this failure to comply with the terms of those estimate of the burden of the
Decision and Order will hopefully deter conditions will constitute an independent proposed collection of information,
Respondent from engaging in future basis for administrative enforcement
including the validity of the
misconduct. As for the Agency’s interest proceedings by the DEA. This consent and
acknowledgement document shall be methodology and assumptions used;
in general deterrence, not only does the —Evaluate whether and if so how the
Agency have an obvious and manifest delivered to the Respondent’s local DEA
Field Office. quality, utility, and clarity of the
interest in deterring violations of the information to be collected can be
CSA and DEA’s regulations by members This Order is effective October 19,
enhanced; and
of the regulated community, the Agency 2018.
—Minimize the burden of the collection
also has a manifest interest in ensuring Dated: September 5, 2018. of information on those who are to
that those members to whom it extends Uttam Dhillon, respond, including through the use of
the forbearance of an MOA will comply Acting Administrator. appropriate automated, electronic,
with the terms of those agreements. mechanical, or other technological
[FR Doc. 2018–20383 Filed 9–18–18; 8:45 am]
Roberto Zayas, M.D., 82 FR 21410, collection techniques or other forms
BILLING CODE 4410–09–P
21430 (2017). of information technology, e.g.,
I therefore conclude that the
permitting electronic submission of
suspension of Respondent’s DEA
DEPARTMENT OF JUSTICE responses.
registration for one month, in addition
to the imposition of the ALJ’s [OMB Number 1121–0065] Overview of This Information
recommended restrictions at the Collection
conclusion of Respondent’s one-month Agency Information Collection
Activities; Proposed eCollection (1) Type of Information Collection:
suspension, are necessary to protect the Extension of a Currently Approved
public interest. eComments Requested; Extension of a
Currently Approved Collection: Collection.
Order National Corrections Reporting (2) The Title of the Form/Collection:
Pursuant to the authority vested in me Program National Corrections Reporting Program.
by 21 U.S.C. 823(f) and 824(a), as well The collection includes the following
AGENCY: Bureau of Justice Statistics, parts: Prisoner Admission Report,
as 28 CFR 0.100(b), I order that DEA
Department of Justice. Prisoner Release Report, Prisoners in
Certificate of Registration No.
BN4578057, issued to Brian Thomas ACTION: 30-Day notice. Custody at Year-end Report, Post-
Nichol, M.D., be, and it hereby is, Custody Community Supervision Entry
SUMMARY: The Department of Justice Report, Post-Custody Community
suspended for one month. At the (DOJ), Office of Justice Programs,
conclusion of this one-month Supervision Exit Report.
Bureau of Justice Statistics, will be (3) The agency form number, if any,
suspension, I impose the following submitting the following information
restrictions on Brian Thomas Nichol’s and the applicable component of the
collection request to the Office of Department sponsoring the collection:
DEA Certificate of Registration No. Management and Budget (OMB) for Form number(s): NCRP–1A, NCRP–1B,
amozie on DSK3GDR082PROD with NOTICES1
BN4578057: review and approval in accordance with NCRP–1D, NCRP–1E, NCRP–1F. The
1. That he may not participate in any drug the Paperwork Reduction Act of 1995. applicable component within the
studies in which he is required to order, DATES: Comments are encouraged and Department of Justice is the Bureau of
maintain, store, or dispense controlled will be accepted for 30 days until
substances for a period of four years. Justice Statistics (Corrections Unit), in
2. That he may not order, maintain, store, October 19, 2018. the Office of Justice Programs.
or dispense any controlled substances at his FOR FURTHER INFORMATION CONTACT: If (4) Affected public who will be asked
registered location for a period of four years. you have additional comments or required to respond, as well as a brief
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Document Created: 2018-09-19 02:55:55
Document Modified: 2018-09-19 02:55:55
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 47352 |
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